# K151305: SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Aug 27, 2015 after 101 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: 11 generations back to K931154 (1993). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K190560: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface (2019), 0 descendants of its own

## Indications for use
Model 8203CA The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments. Model 8204CA The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

Source page: https://510kreport.com/device/K151305
Methodology: https://510kreport.com/methodology