FDA 510(k) · Masimo
K082052: MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK (Masimo Corporation)
Masimo Corporation received FDA 510(k) K082052 for MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK, with a decision date of Oct 10, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K082052 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 21, 2008 |
| Decision date | Oct 10, 2008 |
| 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 Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Indications For Use: The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings. i (DivisIOn Sigft-Off) Divislo f Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: } uY4-&K) Prescription Use X AND/OR Over-The-Counter Use (Per 21 CFRI 801.109 Subpart D) (Per 21 C=ll 801.109 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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.
- K080238 MASIMO RAINBOW SET RADICAL 7 PULSE CO-O… (Masimo)
Later records that cite K082052
- K091057 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES (Masimo, Jul 9, 2009, 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.