# K230277: Pulse Oximeter (Model OHT60,OXH78)

- Pathway: 510(k) (Traditional)
- Applicant: Cofoe Medical Technology Co., Ltd.
- Decided: Jan 4, 2024 after 337 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: 8 generations back to K001085 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212665: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911), Huizhou Xiaoou Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion.

Source page: https://510kreport.com/device/K230277
Methodology: https://510kreport.com/methodology