# K123801: Finger Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kingyield Technology Co., Ltd.
- Decided: May 28, 2013 after 169 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: 4 generations back to K001085 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093757: MD300C1 Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 2.

## Indications for use
PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO 2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

Source page: https://510kreport.com/device/K123801
Methodology: https://510kreport.com/methodology