Adverse-event reports (MAUDE)
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
- K232389
- K162675
- K183697
- K213234
- K221348
- K221953
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-20 | NAI | No action indicated | Masimo Corporation | 0 |
| 2024-08-20 | NAI | No action indicated | Masimo Corporation | 0 |
| 2024-03-08 | NAI | No action indicated | MASIMO CORPORATION | 0 |
| 2024-03-08 | NAI | No action indicated | MASIMO CORPORATION | 0 |
| 2019-10-15 | NAI | No action indicated | Masimo Corporation, Inc | 0 |
| 2018-09-13 | NAI | No action indicated | Masimo Corporation | 0 |
| 2017-05-05 | NAI | No action indicated | Masimo Corporation | 0 |
| 2014-08-13 | WL | Warning Letter | Masimo Corporation | — |
| 2014-03-27 | VAI | Voluntary action indicated | Industrial Vallera de Mexicali, S. A. de C. V. | 4 |
| 2013-10-03 | OAI | Official action indicated | Masimo Corporation | 9 |
| 2011-02-11 | NAI | No action indicated | Masimo Corporation | 0 |
| 2010-02-03 | NAI | No action indicated | Masimo Corporation | 0 |
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