# K190560: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: May 2, 2019 after 58 days
- Product code: MUD (Oximeter, Tissue Saturation)
- 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: 12 generations back to K931154 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102715: Regional Oximeter, Nonin Medical, Inc. (2010) Summary page 4.
- K151305: SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg), Nonin Medical, Inc. (2015) Summary page 4.

## Indications for use
The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rS02) of blood underneath the sensor of adult and pediatric patients weighing ~ 88 pounds (~ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment. Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Noni n's Model 8006CA sensor. The sensor and patient interface is intended for use in hospitals, long-term care, medical faci lities, sleep laboratories, and subacute environments.

Source page: https://510kreport.com/device/K190560
Methodology: https://510kreport.com/methodology