# K101577: Modification to:Fingertip Pulse Oximeter, Model MD300C Series

- Pathway: 510(k) (Special)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Dec 2, 2010 after 178 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070371: Fingertip Pulse Oximeter MD300C, Beijing Choice Electronic Technololgy Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K212385: YUWELL Finger Pulse Oximeter (2022), 1 descendant of its own
- K252805: YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (2026), 0 descendants of its own

## Indications for use
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units). Not for continuous monitoring.

Source page: https://510kreport.com/device/K101577
Methodology: https://510kreport.com/methodology