# K180685: AS-3XX Series Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Acurio Instruments Co., Ltd.
- Decided: Nov 29, 2018 after 259 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)
- K140582: Fingertip Pulse Oximeter, Shenzhen Jumper Medical Equipment Co., Ltd. (2014) Summary page 5.

## Indications for use
The AS-3XX Series Fingertip Pulse Oximeter (with models AS-301, AS-302, AS-301-L, AS-302-L, AS-303, AS-304, AS-304-L and AS-311) is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult in hospitals, hospital-type facilities, and home environments.

Source page: https://510kreport.com/device/K180685
Methodology: https://510kreport.com/methodology