# K221953: Masimo CARESCAPE SpO2 – Masimo with SpHb

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Aug 4, 2022 after 30 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: 14 generations back to K941811 (1994). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212876: Carescape SpO2 - Masimo, Masimo Corporation (2021) Summary page 4.
- K213234: CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201, Ge Medical Systems Information Technologies, Inc. (2022) Summary page 4.

## Most influential descendants
- 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 continuous non-invasive 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 non-invasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.

Source page: https://510kreport.com/device/K221953
Methodology: https://510kreport.com/methodology