# K221798: Finger Pulse Oximeter, Model: X1906P

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changkun Technology Co., Ltd.
- Decided: May 4, 2023 after 317 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: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160268: Fingertip Pulse Oximeter MD300CG11/MD300CG51, Beijing Choice Electronic Technology Co., Ltd. (2016) Summary page 5.

## Indications for use
The Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.

Source page: https://510kreport.com/device/K221798
Methodology: https://510kreport.com/methodology