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1-Slot CO2 Module w/ kit (Adult/Ped)

Model 115-049134-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06936415902742

CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400

UDILibrary device dossier · generated 2026-09-13 · 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.

47931401862019-01: 0 reports for this device; peer average 2.8/device2019-02: 0 reports for this device; peer average 1.29/device2019-03: 0 reports for this device; peer average 1.2/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 1.91/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.8/device2019-08: 0 reports for this device; peer average 2.33/device2019-09: 0 reports for this device; peer average 1.85/device2019-10: 0 reports for this device; peer average 2.2/device2019-11: 0 reports for this device; peer average 2.44/device2019-12: 0 reports for this device; peer average 3.29/device2020-01: 0 reports for this device; peer average 1.8/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3.2/device2020-04: 0 reports for this device; peer average 1.83/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 4.4/device2020-09: 0 reports for this device; peer average 19.25/device2020-10: 0 reports for this device; peer average 19.67/device2020-11: 0 reports for this device; peer average 60.38/device2020-12: 0 reports for this device; peer average 186/device2021-01: 0 reports for this device; peer average 111/device2021-02: 0 reports for this device; peer average 13.75/device2021-03: 0 reports for this device; peer average 9.56/device2021-04: 0 reports for this device; peer average 6.54/device2021-05: 0 reports for this device; peer average 9.43/device2021-06: 0 reports for this device; peer average 17.33/device2021-07: 0 reports for this device; peer average 16.89/device2021-08: 0 reports for this device; peer average 11/device2021-09: 0 reports for this device; peer average 9.8/device2021-10: 0 reports for this device; peer average 15.37/device2021-11: 0 reports for this device; peer average 15.92/device2021-12: 0 reports for this device; peer average 38.83/device2022-01: 0 reports for this device; peer average 31/device2022-02: 0 reports for this device; peer average 23.38/device2022-03: 0 reports for this device; peer average 38.75/device2022-04: 0 reports for this device; peer average 21.5/device2022-05: 0 reports for this device; peer average 20.89/device2022-06: 0 reports for this device; peer average 17.8/device2022-07: 0 reports for this device; peer average 20.5/device2022-08: 0 reports for this device; peer average 13.74/device2022-09: 0 reports for this device; peer average 16/device2022-10: 0 reports for this device; peer average 14.92/device2022-11: 0 reports for this device; peer average 18/device2022-12: 0 reports for this device; peer average 29.38/device2023-01: 0 reports for this device; peer average 14.7/device2023-02: 0 reports for this device; peer average 22/device2023-03: 0 reports for this device; peer average 22.25/device2023-04: 0 reports for this device; peer average 28.75/device2023-05: 0 reports for this device; peer average 25.5/device2023-06: 0 reports for this device; peer average 20.89/device2023-07: 0 reports for this device; peer average 15.09/device2023-08: 0 reports for this device; peer average 19.29/device2023-09: 0 reports for this device; peer average 12.58/device2023-10: 0 reports for this device; peer average 16/device2023-11: 0 reports for this device; peer average 13.33/device2023-12: 0 reports for this device; peer average 6.18/device2024-01: 0 reports for this device; peer average 9.29/device2024-02: 0 reports for this device; peer average 20.18/device2024-03: 0 reports for this device; peer average 17.58/device2024-04: 0 reports for this device; peer average 9.14/device2024-05: 0 reports for this device; peer average 7/device2024-06: 0 reports for this device; peer average 9.14/device2024-07: 0 reports for this device; peer average 10.54/device2024-08: 0 reports for this device; peer average 12.54/device2024-09: 0 reports for this device; peer average 16.7/device2024-10: 0 reports for this device; peer average 11.76/device2024-11: 0 reports for this device; peer average 8.86/device2024-12: 0 reports for this device; peer average 17.89/device2025-01: 0 reports for this device; peer average 8.11/device2025-02: 0 reports for this device; peer average 9.6/device2025-03: 0 reports for this device; peer average 11.11/device2025-04: 0 reports for this device; peer average 14.31/device2025-05: 0 reports for this device; peer average 11.39/device2025-06: 0 reports for this device; peer average 10.14/device2025-07: 0 reports for this device; peer average 23.13/device2025-08: 0 reports for this device; peer average 10/device2025-09: 0 reports for this device; peer average 7.7/device2025-10: 0 reports for this device; peer average 12.53/device2025-11: 0 reports for this device; peer average 11/device2025-12: 0 reports for this device; peer average 16.29/device2026-01: 0 reports for this device; peer average 11.4/device2026-02: 0 reports for this device; peer average 16.38/device2026-03: 0 reports for this device; peer average 10.64/device2026-04: 0 reports for this device; peer average 14.65/device2026-05: 0 reports for this device; peer average 26/device2026-06: 0 reports for this device; peer average 49.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.8
2019-0201.29
2019-0301.2
2019-0401.71
2019-0501.91
2019-0601.5
2019-0701.8
2019-0802.33
2019-0901.85
2019-1002.2
2019-1102.44
2019-1203.29
2020-0101.8
2020-0202
2020-0303.2
2020-0401.83
2020-0501.5
2020-0603
2020-0702.17
2020-0804.4
2020-09019.25
2020-10019.67
2020-11060.38
2020-120186
2021-010111
2021-02013.75
2021-0309.56
2021-0406.54
2021-0509.43
2021-06017.33
2021-07016.89
2021-08011
2021-0909.8
2021-10015.37
2021-11015.92
2021-12038.83
2022-01031
2022-02023.38
2022-03038.75
2022-04021.5
2022-05020.89
2022-06017.8
2022-07020.5
2022-08013.74
2022-09016
2022-10014.92
2022-11018
2022-12029.38
2023-01014.7
2023-02022
2023-03022.25
2023-04028.75
2023-05025.5
2023-06020.89
2023-07015.09
2023-08019.29
2023-09012.58
2023-10016
2023-11013.33
2023-1206.18
2024-0109.29
2024-02020.18
2024-03017.58
2024-0409.14
2024-0507
2024-0609.14
2024-07010.54
2024-08012.54
2024-09016.7
2024-10011.76
2024-1108.86
2024-12017.89
2025-0108.11
2025-0209.6
2025-03011.11
2025-04014.31
2025-05011.39
2025-06010.14
2025-07023.13
2025-08010
2025-0907.7
2025-10012.53
2025-11011
2025-12016.29
2026-01011.4
2026-02016.38
2026-03010.64
2026-04014.65
2026-05026
2026-06049.6
This device (reports/month)Average device in CCK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170876 — cites (transitively): K152902 (d1), K161531 (d1), K101521 (d2), K143195 (d2), K150352 (d2), K150632 (d2), K150310 (d2), K150975 (d2), K151681 (d2), K003621 (d3), K030738 (d3), K073376 (d3), K092449 (d3), K123074 (d3), K132026 (d3), K132037 (d3), K132075 (d3), K020550 (d3), K062098 (d3), K070791 (d3), K072235 (d3), K091834 (d3), K132036 (d3), K132038 (d3), K132662 (d3), K142601 (d3), K021788 (d3), K030038 (d3), K031481 (d3), K032858 (d3), K040304 (d3), K041235 (d3), K042845 (d3), K050141 (d3), K050762 (d3), K051106 (d3), K052801 (d3), K053522 (d3), K060221 (d3), K060541 (d3), K061052 (d3), K061610 (d3), K062283 (d3), K062392 (d3), K063315 (d3), K063725 (d3), K071426 (d3), K072020 (d3), K081793 (d3), K082633 (d3), K083517 (d3), K091927 (d3), K093268 (d3), K100939 (d3), K101449 (d3), K102562 (d3), K110474 (d3), K110622 (d3), K113441 (d3), K113657 (d3), K120366 (d3), K120657 (d3), K122439 (d3), K130849 (d3), K131872 (d3), K141015 (d3), K021778 (d4), K033444 (d4), K033513 (d4), K040357 (d4), K171426 (d4), K172020 (d4), K013199 (d4), K093260 (d4), K033296 (d4), K080238 (d4), K092838 (d4), K101896 (d4), K052961 (d4), K082583 (d4), K080192 (d4), K091786 (d4), K031760 (d4), K051212 (d5), K131861 (d5), K141077 (d5), K081888 (d5), K101923 (d5), P960025 (d5), K081917 (d6), K090993 (d6) — cited as predicate by K171292, K171311, K183238, K190011, K191106

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

Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
  • VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations