FDA 510(k) · Masimo
K091057: MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES (Masimo Corporation)
Masimo Corporation received FDA 510(k) K091057 for MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES, with a decision date of Jul 9, 2009 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K091057 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 13, 2009 |
| Decision date | Jul 9, 2009 |
| 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): 0 0 S~ Device Name: Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories Indications For Use: The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospitals, hospital-type facilities, home, clinics, physician. offices, blood donation facilities, and ambulatory surgery centers). Prescription Use __ X AND/OR Over-The-Counter Use (Per 21 CFR 801.109 SubpartD)) (Per.21 CER 8011,09 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED) o~"~-- .~is'on va~C. Iuie of CDRH, Office of Device Evaluation (ODE) 7(!ivision Sin - f ) : '. . .. Division of Anesthesiology, General Hospital Idection Control, Dental Devices 510(k) Number: C01 i, Masimo Pronto, Special 510(k), 4110109: Page 12 of-88
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.
- K082052 MASIMO RAINBOW SET RADCHECK PULSE CO-OX… (Masimo)
Later records that cite K091057
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.