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Rainbow

Model 3777 · MASIMO CORPORATION · DI 00843997012751

DSA — Cable, Transducer And Electrode, Patient, (Including Connector) · Class II · 21 CFR 870.2900

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.

23572019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 6/device2020-07: 0 reports for this device; peer average 1.67/device2020-08: 0 reports for this device; peer average 6/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 5/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1.33/device2021-03: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2.25/device2021-10: 0 reports for this device; peer average 1.8/device2021-11: 0 reports for this device; peer average 2.5/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1.25/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.8/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2.86/device2022-07: 0 reports for this device; peer average 2.63/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1.2/device2022-10: 0 reports for this device; peer average 1.67/device2022-11: 0 reports for this device; peer average 2.25/device2022-12: 0 reports for this device; peer average 1.4/device2023-01: 0 reports for this device; peer average 1.2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.43/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 1.25/device2023-06: 0 reports for this device; peer average 1.8/device2023-07: 0 reports for this device; peer average 1.33/device2023-08: 0 reports for this device; peer average 1.22/device2023-09: 0 reports for this device; peer average 1.25/device2023-10: 0 reports for this device; peer average 1.4/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.6/device2024-02: 0 reports for this device; peer average 1.14/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 5.67/device2024-06: 0 reports for this device; peer average 2.5/device2024-07: 0 reports for this device; peer average 2.75/device2024-08: 0 reports for this device; peer average 6.5/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.8/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 4.17/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 3.2/device2025-03: 0 reports for this device; peer average 2.5/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 6.6/device2025-06: 0 reports for this device; peer average 3.25/device2025-07: 0 reports for this device; peer average 1.57/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 2.38/device2025-11: 0 reports for this device; peer average 2.67/device2025-12: 0 reports for this device; peer average 2.38/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 5.67/device2026-03: 0 reports for this device; peer average 3.13/device2026-04: 0 reports for this device; peer average 3.43/device2026-05: 0 reports for this device; peer average 3.22/device2026-06: 0 reports for this device; peer average 3.75/device0405060708091012010206070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2019-0501.67
2019-0601.33
2019-0701.33
2019-0802
2019-0901
2019-1001.5
2019-1201.5
2020-0101
2020-0201
2020-0606
2020-0701.67
2020-0806
2020-0902
2020-1005
2020-1101
2020-1201
2021-0101
2021-0201.33
2021-0301.5
2021-0401.5
2021-0501
2021-0601.5
2021-0701.33
2021-0801
2021-0902.25
2021-1001.8
2021-1102.5
2021-1201
2022-0101.25
2022-0201
2022-0301.8
2022-0403
2022-0502
2022-0602.86
2022-0702.63
2022-0802
2022-0901.2
2022-1001.67
2022-1102.25
2022-1201.4
2023-0101.2
2023-0201
2023-0301.43
2023-0401.5
2023-0501.25
2023-0601.8
2023-0701.33
2023-0801.22
2023-0901.25
2023-1001.4
2023-1101.5
2023-1201
2024-0101.6
2024-0201.14
2024-0301
2024-0402
2024-0505.67
2024-0602.5
2024-0702.75
2024-0806.5
2024-0902
2024-1001.8
2024-1101.5
2024-1204.17
2025-0101.75
2025-0203.2
2025-0302.5
2025-0401.5
2025-0506.6
2025-0603.25
2025-0701.57
2025-0802.5
2025-0902
2025-1002.38
2025-1102.67
2025-1202.38
2026-0101.71
2026-0205.67
2026-0303.13
2026-0403.43
2026-0503.22
2026-0603.75
This device (reports/month)Average device in DSA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K040259 — cited as predicate by K121914, K162675, K212876

K232389 — cites (transitively): K162675 (d1), K183697 (d1), K213234 (d1), K221348 (d1), K221953 (d1), K040259 (d2), K150975 (d2), K153225 (d2), K180046 (d2), K110028 (d2), K182868 (d2), K190008 (d2), K191149 (d2), K191249 (d2), K191323 (d2), K200494 (d2), K123043 (d2), K162603 (d2), K171121 (d2), K172890 (d2), K210906 (d2), K212876 (d2), K100428 (d3), K081601 (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), K051874 (d3), K071047 (d3), K103604 (d3), K142394 (d3), K082327 (d3), K140188 (d3), K151644 (d3), K160526 (d3), K980327 (d3), K051212 (d3), K101896 (d3), K111888 (d3), K170168 (d3), K011000 (d3), K022834 (d3), K051367 (d3), K053174 (d3), K071073 (d3), K080251 (d3), K083750 (d3), K132533 (d3), K151063 (d3), K171580 (d3), K172482 (d3), K900598 (d3), K131223 (d3), K150245 (d3), K131414 (d3), K161531 (d3), K212867 (d3), K021778 (d4), K033444 (d4), K033513 (d4), K040357 (d4), K171426 (d4), K172020 (d4), K080238 (d4), K091241 (d4), K051092 (d4), K013199 (d4), K093260 (d4), K033296 (d4), K092838 (d4), K102239 (d4), K092027 (d4), K052961 (d4), K082583 (d4), K121013 (d4), K123195 (d4), K032582 (d4), K052582 (d4), K053269 (d4), K060576 (d4), K061907 (d4), K133576 (d4), K133882 (d4), K150298 (d4), K090989 (d4), K101680 (d4), K133879 (d4), K150310 (d4), K151681 (d4), K042346 (d4), K042536 (d4), K162012 (d4), K141518 (d4), K153496 (d4), K040490 (d5), K061185 (d5), K092680 (d5), K102715 (d5), K062976 (d5), K092369 (d5), K110132 (d5), K842308 (d5), K111933 (d5), K121806 (d5), K123581 (d5), K130320 (d5), K062580 (d5), K082540 (d5), K103129 (d5), K133070 (d5), K131861 (d5), K141077 (d5), K081888 (d5), K101923 (d5), P960025 (d5), K060833 (d6), K081917 (d6), K072502 (d6), K083639 (d6), K051896 (d6), K083325 (d6), K012891 (d6), K120773 (d6), K090993 (d6), K131879 (d6)

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

Manufacturer compliance record — MASIMO CORPORATION

  • Warning Letter 2014-08-13 Masimo Corporation
  • NAI 2024-08-20 Masimo Corporation · 0 citations
  • NAI 2024-08-20 Masimo Corporation · 0 citations
  • NAI 2024-03-08 MASIMO CORPORATION · 0 citations
  • NAI 2024-03-08 MASIMO CORPORATION · 0 citations
  • NAI 2019-10-15 Masimo Corporation, Inc · 0 citations
  • NAI 2018-09-13 Masimo Corporation · 0 citations
  • NAI 2017-05-05 Masimo Corporation · 0 citations
  • VAI 2014-03-27 Industrial Vallera de Mexicali, S. A. de C. V. · 4 citations
  • OAI 2013-10-03 Masimo Corporation · 9 citations
  • NAI 2011-02-11 Masimo Corporation · 0 citations
  • NAI 2010-02-03 Masimo Corporation · 0 citations