# K171241: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
- Decided: Mar 27, 2018 after 334 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: 7 generations back to K962603 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051352: Oximax NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2005) Summary page 4.

## Indications for use
The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.

Source page: https://510kreport.com/device/K171241
Methodology: https://510kreport.com/methodology