FDA 510(k) · Masimo
K113596: MASIMO SET REUSABLE OXIMETRY SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K113596 for MASIMO SET REUSABLE OXIMETRY SENSORS, with a decision date of Feb 24, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K113596 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET REUSABLE OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Dec 5, 2011 |
| Decision date | Feb 24, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
510(k) Number:.KII 5\ Device Name: Masimo SET® Reusable Soft Oximetry Sensors Indications for Use: The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive (SPO2) monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin and pediatric patients during and pulse rate (measured by an SP02 sensor) for use with adult hospitals, hospital- no motion conditions, and for patients who are well or poorly perfused in type facilities, mobile, and home environments. Prescription Use X AND/OR Over-The-Counter Use ___ (Part 21 CER 801 Subpart D) (21 CFR 801 Subpart C) PAGE IFNEEDED) (PLEASE DO NOT WRITE BELOW TIElS LINE-CONTINUE ON ANOTHER Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 51Q0k) Number:
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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 DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.