FDA 510(k) · Masimo
K012992: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES (Masimo Corp.)
Masimo Corp. received FDA 510(k) K012992 for MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES, with a decision date of Oct 3, 2001 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K012992 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 6, 2001 |
| Decision date | Oct 3, 2001 |
| 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 (if known): KO1\24 92 Device Name: Masimo SET® Radical Pulse Oximeter with SatShare™ and the Masimo Series of Sensors and Cables Indications For Use: The following additional Masimo Sensors are indicated for the continuous noninvasive functional oxygen saturation of arterial hemoglobin (SpO;) and pulse rate: Single use oximetry sensor intended for adults and pediatrics greater than 10 kg Reusable oximetry ear sensor intended for adults and pediatrics greater than 30 kg Reusable oximetry multisite sensor intended for adults, pediatrics, and neonates greater than | kg (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) S100) Number Reser ens UDoO Prescription Use ae or Over-The-Counter Use were (Per 21 CFR 801.109) (Optional Format 1-2-96) 510(k) Masimo SET® Radical Pulse Oximeter with SatShare™
Extracted automatically from FDA's 510(k) summary with OCR. 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.
Later records that cite K012992
- K111621 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS (Masimo, Oct 26, 2011, DQA)
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.