# K172616: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Safe Heart Technology, Ltd.
- Decided: Jul 27, 2018 after 330 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: 3 generations back to K001085 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130947: Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2013) Summary page 4.

## Indications for use
PULSE OXIMETER SHO-3002,SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc ).It is not for continuously monitoring.

Source page: https://510kreport.com/device/K172616
Methodology: https://510kreport.com/methodology