# K152563: Pulse Oximeter (MD300M/MD300K2)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Apr 18, 2016 after 222 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: 15 generations back to K941811 (1994). 104 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090599: MD300K1 Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2023), 1 descendant of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2026), 0 descendants of its own

## Indications for use
The Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.

Source page: https://510kreport.com/device/K152563
Methodology: https://510kreport.com/methodology