# K090671: Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60D

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Jun 11, 2009 after 90 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.
3 later devices descend from it; 2 cite it directly.
0 of 107 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
- K141362: Pulse Oximeter CMS50EW (2015), 1 descendant of its own
- K172141: Pulse Oximeter (2018), 0 descendants of its own
- K130056: Patient Monitor (2013), 0 descendants of its own

## Indications for use
The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.

Source page: https://510kreport.com/device/K090671
Methodology: https://510kreport.com/methodology