# K090599: MD300K1 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Jul 20, 2009 after 137 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: 14 generations back to K941811 (1994). 103 ancestors in all.
9 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)
- K072581: PM-60 Pulse Oximeter, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K152563: Pulse Oximeter (MD300M/MD300K2) (2016), 8 descendants of its own
- 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

## Indications for use
The MD300KI 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/K090599
Methodology: https://510kreport.com/methodology