# K202743: Med-Link Temp-pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Mar 1, 2021 after 164 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: 10 generations back to K910772 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191403: Pulse Oximeter, Nonin Medical, Inc. (2019) Summary page 5.

## Indications for use
Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician’s office, clinical settings and home care environment. It’s a reusable device intended for adults and pediatrics who are well or poorly perfused.

Source page: https://510kreport.com/device/K202743
Methodology: https://510kreport.com/methodology