# K160231: Model X-100C CO-Met™ Oximetry System

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Dec 23, 2016 after 326 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: 6 generations back to K000126 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter, Masimo Corporation (2006) Summary page 4.

## Most influential descendants
- K172625: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (2018), 0 descendants of its own

## Indications for use
Nonin’s Model X‐100C CO‐Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot‐checks to observe change and/or continuous monitoring. The X‐100C system is indicated for use by trained personnel in clinical and non‐clinical settings, including Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. 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. The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be multiple spot‐checks to observe change and/or continuous monitoring. It is intended for use in Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. 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.

Source page: https://510kreport.com/device/K160231
Methodology: https://510kreport.com/methodology