# K192900: H500 Multi-Sensing Oximetry System

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jun 29, 2020 after 258 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: 13 generations back to K931154 (1993). 83 ancestors in all.
No later device cites it as a predicate yet.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132402: Sensmart Model X-100 Univeral Oximetry System, Nonin Medical, Inc. (2014) Summary page 4.

## Indications for use
The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). 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 H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings. • For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings. • For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

Source page: https://510kreport.com/device/K192900
Methodology: https://510kreport.com/methodology