FDA 510(k) · Masimo
K042536: MASIMO SET RAD 57 PULSE CO-OXIMETER (Masimo Corporation)
Masimo Corporation received FDA 510(k) K042536 for MASIMO SET RAD 57 PULSE CO-OXIMETER, with a decision date of Jan 19, 2005 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K042536 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET RAD 57 PULSE CO-OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 20, 2004 |
| Decision date | Jan 19, 2005 |
| 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
510(k) Number (if known): K042536 Device Name: Masimo Rainbow SET Rad 57 Pulse CO-Oximeter Indications For Use: for the continuous noninvasive The Masimo Rainbow SET Rad 57 Pulse CO-Oximeter and accessories are indicated ® monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO2 sensor) Masimo SET® Rad 57 and accessories are and carboxyhernoglobin saturation (measured by an SpCO sensor). The no motion and motion conditions, and for indicated fbr use with adult, pediatric, and neonatal patients during both facilities, mobile, and home environments. patients who are well or poorly perfused in hospitals, hospital-type Prescription Use _X_ AND/OR Over'The'Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign i~f)~/ Division of Anes'tffesiology, General Hospital, Infection Control, Dental Devices 510(k) Number. - O4 15 3 (4
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.