# K172625: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: May 11, 2018 after 252 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: 7 generations back to K000126 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160231: Model X-100C CO-Met™ Oximetry System, Nonin Medical, Inc. (2016) Summary page 4.

## Indications for use
The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. • For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg). • For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Source page: https://510kreport.com/device/K172625
Methodology: https://510kreport.com/methodology