FDA 510(k) · Masimo
K080238: MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER (Masimo Corporation)
Masimo Corporation received FDA 510(k) K080238 for MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER, with a decision date of May 12, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K080238 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jan 31, 2008 |
| Decision date | May 12, 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
We could not extract the indications for this record. Check the FDA record for its summary or statement.
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 K080238
- K182887 Masimo Rad-67 Pulse CO-Oximeter and Accessories (Masimo, Mar 22, 2019, DQA)
- K100428 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER (Masimo, Jul 9, 2010, DQA)
- K082052 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK (Masimo, Oct 10, 2008, DQA)
- K081659 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L (Masimo, Sep 9, 2008, 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.