# K161938: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
- Decided: May 8, 2017 after 298 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: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142687: Pulse Oximeter, Shanghai Berry Electronic Tech Co., Ltd. (2015) Summary page 6.
- K093757: MD300C1 Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 6.

## Indications for use
The pulse oximeter (YK-81C) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring.

Source page: https://510kreport.com/device/K161938
Methodology: https://510kreport.com/methodology