# K240808: Pulse Oximeter (WS20A)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
- Decided: Oct 3, 2024 after 192 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: 6 generations back to K001085 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172366: Wrist Pulse Oximeter, Beijing Choice Electronic Technology Co., Ltd. (2018) Summary page 5.

## Indications for use
WS20A is a pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for patients(=10 years old, =30kg). It is designed for finger circumference more than 33mm. It is intended for spot-check, continuous data collection, recording and transmitting, not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home.

Source page: https://510kreport.com/device/K240808
Methodology: https://510kreport.com/methodology