# K111494: Handheld Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Jan 18, 2012 after 232 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: 9 generations back to K910772 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092620: MD300C318 Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2009) Summary page 2.

## Indications for use
The MD 300M122/MD300M222/MD300M322 handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.

Source page: https://510kreport.com/device/K111494
Methodology: https://510kreport.com/methodology