# K092620: MD300C318 Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Dec 4, 2009 after 100 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: 8 generations back to K910772 (1991). 18 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081285: Finger Pulse Oximeter, Model 9560, Nonin Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K142888: Fingertip Pulse Oximeter (2015), 8 descendants of its own
- K181503: Fingertip Pulse Oximeter (2018), 6 descendants of its own
- K230172: Pulse Oximeter (2023), 1 descendant of its own
- K250837: Pulse Oximeter (2025), 0 descendants of its own
- K243049: Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) (2025), 0 descendants of its own

## Indications for use
The MD300C318 Fingertip Pulse Oximeter is intended for continuous use or spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick.

Source page: https://510kreport.com/device/K092620
Methodology: https://510kreport.com/methodology