FDA 510(k) · Masimo
K162675: Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Masimo Corporation)
Masimo Corporation received FDA 510(k) K162675 for Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter, with a decision date of Dec 28, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K162675 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 26, 2016 |
| Decision date | Dec 28, 2016 |
| 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
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies. The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused. 7KH0DVLPR5DLQERZ6(7,QWHOOLYXH0RGXOH3XOVH&22[LPHWHULVQRWLQWHQGHGWREHXVHGDVWKHVROHEDVLVIRU PDNLQJGLDJQRVLVRUWUHDWPHQWGHFLVLRQVUHODWHGWRVXVSHFWHGFDUERQPRQR[LGHSRLVRQLQJ LWLVLQWHQGHGWREH XVHGLQFRQMXQFWLRQZLWKDGGLWLRQDOPHWKRGVRIDVVHVVLQJFOLQLFDOVLJQVDQGV\PSWRPV
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.
Later records that cite K162675
- K232389 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (Masimo, Sep 7, 2023, 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.