FDA 510(k) · Masimo
K191882: Masimo Centroid System (Masimo Corporation)
Masimo Corporation received FDA 510(k) K191882 for Masimo Centroid System, with a decision date of Apr 22, 2020 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K191882 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Centroid System |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Jul 15, 2019 |
| Decision date | Apr 22, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement patients including those susceptible to pressure ulcers. The Centroid System is intended for use in healthcare environments. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. Prescription Use X AND/OR Over The Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) AI Response for K191882 S001 Masimo Centroid System
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K191882
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.