# K211632: Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Narig Bio-Medical Technology Co., Ltd.
- Decided: Jan 14, 2022 after 232 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: 20 generations back to K962603 (1997). 111 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 113 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter, Masimo Corporation (2019) Summary page 4.

## Most influential descendants
- K222213: Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) (2022), 0 descendants of its own

## Indications for use
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric (>10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused. Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.

Source page: https://510kreport.com/device/K211632
Methodology: https://510kreport.com/methodology