# K252655: Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO,  PO-C6AT)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
- Decided: May 11, 2026 after 262 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: 6 generations back to K001085 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173123: Pulse Oximeter, Shenzhen Imdk Medical Technology Co., Ltd. (2018) Summary page 6.

## Indications for use
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the fingertip. This portable device is indicated for use in adult patients in hospitals, professional healthcare facilities, and home environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse.

Source page: https://510kreport.com/device/K252655
Methodology: https://510kreport.com/methodology