FDA 510(k) · Masimo
K053477: MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K053477 for MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS, with a decision date of Mar 16, 2006 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K053477 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Dec 14, 2005 |
| Decision date | Mar 16, 2006 |
| 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): Device Name: Masimo SET Rad 57 cm and m Pulse CO-Oximeters Indications For Use: The Masimo SET® Rad-57 cm Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive 0 monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP 2 sensor) and carboxyhemoglobin and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 cm Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. The Masimo SET® Rad-57 m Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO2 sensor) and methemoglobin saturation or methemoglobin (measured by an SpCO/SpMet sensor). The Masimo SET® Rad-57 m Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. Prescription Use _X _ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ,r.;:,-geierzl H ,"S. (C%3497
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.
Later records that cite K053477
- K061204 MASIMO SET RADICAL 7 PULSE CO-OXIMETER (Masimo, Jul 27, 2006, 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.