# K212876: Carescape SpO2 - Masimo

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Oct 8, 2021 after 29 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 81 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES, GE Healthcare (2020) Summary page 4.
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 4.

## Most influential descendants
- K221953: Masimo CARESCAPE SpO2 – Masimo with SpHb (2022), 1 descendant of its own
- K232389: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (2023), 0 descendants of its own

## Indications for use
The CARESCAPE SpO2 - Masimo is intended to be used with multi-parameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE SpO2 — Masimo is indicated for the monitoring of Functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The CARESCAPE SpO2 — Masimo is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.

Source page: https://510kreport.com/device/K212876
Methodology: https://510kreport.com/methodology