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Temperature Probe

Model rectal/oral ,neonatal/Infant,3m,reusable · Edan Instruments, Inc. · DI 06944413804760

FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-01: 0 reports for this device; peer average 5.5/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2.5/device2019-04: 0 reports for this device; peer average 2.5/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 2.4/device2019-07: 0 reports for this device; peer average 2.71/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1.8/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.86/device2020-07: 0 reports for this device; peer average 1.27/device2020-08: 0 reports for this device; peer average 2.67/device2020-09: 0 reports for this device; peer average 1.4/device2020-10: 0 reports for this device; peer average 2.13/device2020-11: 0 reports for this device; peer average 3.67/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.71/device2021-03: 0 reports for this device; peer average 1.09/device2021-04: 0 reports for this device; peer average 2.33/device2021-05: 0 reports for this device; peer average 1.83/device2021-06: 0 reports for this device; peer average 1.86/device2021-07: 0 reports for this device; peer average 1.2/device2021-08: 0 reports for this device; peer average 5.33/device2021-09: 0 reports for this device; peer average 4.57/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.83/device2021-12: 0 reports for this device; peer average 6.33/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 1.83/device2022-03: 0 reports for this device; peer average 4.1/device2022-04: 0 reports for this device; peer average 1.63/device2022-05: 0 reports for this device; peer average 5.33/device2022-06: 0 reports for this device; peer average 2.55/device2022-07: 0 reports for this device; peer average 2.63/device2022-08: 0 reports for this device; peer average 2.43/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2.11/device2022-11: 0 reports for this device; peer average 2.2/device2022-12: 0 reports for this device; peer average 2.2/device2023-01: 0 reports for this device; peer average 2.14/device2023-02: 0 reports for this device; peer average 3.5/device2023-03: 0 reports for this device; peer average 3.78/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2.6/device2023-06: 0 reports for this device; peer average 3.14/device2023-07: 0 reports for this device; peer average 2.5/device2023-08: 0 reports for this device; peer average 1.89/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2.18/device2023-11: 0 reports for this device; peer average 2.57/device2023-12: 0 reports for this device; peer average 2.11/device2024-01: 0 reports for this device; peer average 2.29/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.43/device2024-04: 0 reports for this device; peer average 3.43/device2024-05: 0 reports for this device; peer average 4.75/device2024-06: 0 reports for this device; peer average 2.36/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 3.83/device2024-11: 0 reports for this device; peer average 3.62/device2024-12: 0 reports for this device; peer average 4.29/device2025-01: 0 reports for this device; peer average 3.1/device2025-02: 0 reports for this device; peer average 3.43/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 1.91/device2025-06: 0 reports for this device; peer average 1.75/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 2.1/device2025-09: 0 reports for this device; peer average 2.11/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 4.43/device2025-12: 0 reports for this device; peer average 2.07/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 1.87/device2026-03: 0 reports for this device; peer average 2.08/device2026-04: 0 reports for this device; peer average 1.33/device2026-05: 0 reports for this device; peer average 2.08/device2026-06: 0 reports for this device; peer average 2.06/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.5
2019-0202
2019-0302.5
2019-0402.5
2019-0501
2019-0602.4
2019-0702.71
2019-0803
2019-0901
2019-1003
2019-1101.33
2019-1201.5
2020-0101.5
2020-0201.8
2020-0301
2020-0405
2020-0501
2020-0602.86
2020-0701.27
2020-0802.67
2020-0901.4
2020-1002.13
2020-1103.67
2020-1201.33
2021-0101
2021-0201.71
2021-0301.09
2021-0402.33
2021-0501.83
2021-0601.86
2021-0701.2
2021-0805.33
2021-0904.57
2021-1002
2021-1102.83
2021-1206.33
2022-0103.14
2022-0201.83
2022-0304.1
2022-0401.63
2022-0505.33
2022-0602.55
2022-0702.63
2022-0802.43
2022-0902
2022-1002.11
2022-1102.2
2022-1202.2
2023-0102.14
2023-0203.5
2023-0303.78
2023-0402
2023-0502.6
2023-0603.14
2023-0702.5
2023-0801.89
2023-0902
2023-1002.18
2023-1102.57
2023-1202.11
2024-0102.29
2024-0201.5
2024-0301.43
2024-0403.43
2024-0504.75
2024-0602.36
2024-0704
2024-0803
2024-0902.5
2024-1003.83
2024-1103.62
2024-1204.29
2025-0103.1
2025-0203.43
2025-0301.88
2025-0402.5
2025-0501.91
2025-0601.75
2025-0701.75
2025-0802.1
2025-0902.11
2025-1001.75
2025-1104.43
2025-1202.07
2026-0102.5
2026-0201.87
2026-0302.08
2026-0401.33
2026-0502.08
2026-0602.06
This device (reports/month)Average device in FLL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K152552 — cites (transitively): K102562 (d1), K131971 (d1), K021778 (d2), K030038 (d2), K032858 (d2), K033444 (d2), K041235 (d2), K050762 (d2), K053522 (d2), K082633 (d2), K100939 (d2) — cited as predicate by K173042, K181919

K192514 — cites (transitively): K160981 (d1), K182075 (d1), K182821 (d1), K011291 (d2), K042346 (d2), K042536 (d2), K051212 (d2), K170712 (d2), K132038 (d3), K152902 (d3), K072235 (d4), K101521 (d4), K143195 (d4), K150352 (d4), K150632 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K092449 (d5), K123074 (d5), K132026 (d5), K132037 (d5), K132075 (d5), K020550 (d5), K062098 (d5), K070791 (d5), K091834 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K080192 (d6), K091786 (d6), K102562 (d6), K031760 (d6), K021778 (d7), K030038 (d7), K032858 (d7), K033444 (d7), K041235 (d7), K050762 (d7), K053522 (d7), K082633 (d7), K100939 (d7) — cited as predicate by K202336, K202892, K220308

K232962 — cites (transitively): K180380 (d1), K182075 (d1), K202336 (d1), K202892 (d1), K211475 (d1), K220308 (d1), K120727 (d2), K131818 (d2), K160981 (d2), K192514 (d2), K011291 (d2), K132037 (d2), K171751 (d2), K171888 (d2), K182821 (d2), K191769 (d2), K193391 (d2), K141542 (d2), K200015 (d2), K200594 (d2), K210906 (d2), K003313 (d3), K120144 (d3), K072235 (d3), K051352 (d3), K060576 (d3), K123581 (d3), K120907 (d3), K130411 (d3), K150620 (d3), K151071 (d3), K042346 (d3), K042536 (d3), K051212 (d3), K170712 (d3), K020550 (d3), K062098 (d3), K070791 (d3), K091834 (d3), K092449 (d3), K150352 (d3), K153448 (d3), K172226 (d3), K183238 (d3), K103142 (d3), K141518 (d3), K150272 (d3), K101449 (d3), K110622 (d3), K161531 (d3), K021778 (d4), K100939 (d4), K032858 (d4), K033444 (d4), K042845 (d4), K051106 (d4), K052801 (d4), K062283 (d4), K062392 (d4), K102835 (d4), K111637 (d4), K110361 (d4), K110742 (d4), K110978 (d4), K111594 (d4), K012891 (d4), K083325 (d4), K120773 (d4), K033048 (d4), K111933 (d4), K121806 (d4), K130320 (d4), K112368 (d4), K101521 (d4), K132026 (d4), K143195 (d4), K130740 (d4), K140430 (d4), K102426 (d4), K121914 (d4), K150310 (d4), K150975 (d4), K151681 (d4), K132038 (d4), K152902 (d4), K101600 (d4), K103646 (d4), K111905 (d4), K113125 (d4), K150632 (d4), K162607 (d4), K170876 (d4), K172482 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K033715 (d5), K041741 (d5), K081937 (d5), K090360 (d5), K050230 (d5), K073203 (d5), K040357 (d5), K063725 (d5), K081793 (d5), K081574 (d5), K081828 (d5), K051076 (d5), K060559 (d5), K033474 (d5), K931787 (d5), K062177 (d5), K091265 (d5), K110168 (d5), K083517 (d5), K051896 (d5), K101995 (d5), K040259 (d5), K121912 (d5), K001775 (d5), K090556 (d5), K123074 (d5), K132075 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K021788 (d5), K030038 (d5), K031481 (d5), K040304 (d5), K041235 (d5), K050141 (d5), K050762 (d5), K053522 (d5), K060221 (d5), K060541 (d5), K061052 (d5), K061610 (d5), K063315 (d5), K071426 (d5), K072020 (d5), K082633 (d5), K091927 (d5), K093268 (d5), K102562 (d5), K110474 (d5), K113441 (d5), K113657 (d5), K120366 (d5), K120657 (d5), K122439 (d5), K130849 (d5), K131872 (d5), K141015 (d5), K033513 (d6), K171426 (d6), K172020 (d6), K080238 (d6), K094012 (d6), K042007 (d6), K013199 (d6), K093260 (d6), K033296 (d6), K092838 (d6), K101896 (d6), K052961 (d6), K082583 (d6), K080192 (d6), K091786 (d6), K031760 (d6), K082268 (d7), K131861 (d7), K141077 (d7), K081888 (d7), K101923 (d7), P960025 (d7), K081917 (d8), K090993 (d8) — cited as predicate by K250179, K252250

K250179 — cites (transitively): K180380 (d1), K232962 (d1), K120727 (d2), K131818 (d2), K160981 (d2), K182075 (d2), K202336 (d2), K202892 (d2), K211475 (d2), K220308 (d2), K003313 (d3), K120144 (d3), K192514 (d3), K011291 (d3), K132037 (d3), K171751 (d3), K171888 (d3), K182821 (d3), K191769 (d3), K193391 (d3), K141542 (d3), K200015 (d3), K200594 (d3), K210906 (d3), K102835 (d4), K111637 (d4), K072235 (d4), K051352 (d4), K060576 (d4), K123581 (d4), K120907 (d4), K130411 (d4), K150620 (d4), K151071 (d4), K042346 (d4), K042536 (d4), K051212 (d4), K170712 (d4), K020550 (d4), K062098 (d4), K070791 (d4), K091834 (d4), K092449 (d4), K150352 (d4), K153448 (d4), K172226 (d4), K183238 (d4), K103142 (d4), K141518 (d4), K150272 (d4), K101449 (d4), K110622 (d4), K161531 (d4), K021778 (d5), K100939 (d5), K032858 (d5), K033444 (d5), K042845 (d5), K051106 (d5), K052801 (d5), K062283 (d5), K062392 (d5), K110361 (d5), K110742 (d5), K110978 (d5), K111594 (d5), K012891 (d5), K083325 (d5), K120773 (d5), K033048 (d5), K111933 (d5), K121806 (d5), K130320 (d5), K112368 (d5), K101521 (d5), K132026 (d5), K143195 (d5), K130740 (d5), K140430 (d5), K102426 (d5), K121914 (d5), K150310 (d5), K150975 (d5), K151681 (d5), K132038 (d5), K152902 (d5), K101600 (d5), K103646 (d5), K111905 (d5), K113125 (d5), K150632 (d5), K162607 (d5), K170876 (d5), K172482 (d5), K003621 (d6), K030738 (d6), K073376 (d6), K033715 (d6), K041741 (d6), K081937 (d6), K090360 (d6), K050230 (d6), K073203 (d6), K040357 (d6), K063725 (d6), K081793 (d6), K081574 (d6), K081828 (d6), K051076 (d6), K060559 (d6), K033474 (d6), K931787 (d6), K062177 (d6), K091265 (d6), K110168 (d6), K083517 (d6), K051896 (d6), K101995 (d6), K040259 (d6), K121912 (d6), K001775 (d6), K090556 (d6), K123074 (d6), K132075 (d6), K132036 (d6), K132662 (d6), K142601 (d6), K021788 (d6), K030038 (d6), K031481 (d6), K040304 (d6), K041235 (d6), K050141 (d6), K050762 (d6), K053522 (d6), K060221 (d6), K060541 (d6), K061052 (d6), K061610 (d6), K063315 (d6), K071426 (d6), K072020 (d6), K082633 (d6), K091927 (d6), K093268 (d6), K102562 (d6), K110474 (d6), K113441 (d6), K113657 (d6), K120366 (d6), K120657 (d6), K122439 (d6), K130849 (d6), K131872 (d6), K141015 (d6), K033513 (d7), K171426 (d7), K172020 (d7), K080238 (d7), K094012 (d7), K042007 (d7), K013199 (d7), K093260 (d7), K033296 (d7), K092838 (d7), K101896 (d7), K052961 (d7), K082583 (d7), K080192 (d7), K091786 (d7), K031760 (d7), K082268 (d8), K131861 (d8), K141077 (d8), K081888 (d8), K101923 (d8), P960025 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Edan Instruments, Inc.

  • NAI 2012-11-29 Edan Instruments, Inc. · 0 citations
  • NAI 2012-11-29 Edan Instruments, Inc. · 0 citations