FDA 510(k) · Masimo
K232389: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (Masimo Corporation)
Masimo Corporation received FDA 510(k) K232389 for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue, with a decision date of Sep 7, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K232389 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 9, 2023 |
| Decision date | Sep 7, 2023 |
| 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
The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE SpO2 - Masimo is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE SpO2 - Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time. The CARESCAPE SpO2 - Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.
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.
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.