# K961790: Point-of-Care Blood Gas Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Optical Sensors, Inc.
- Decided: Apr 9, 1997 after 335 days
- Product code: CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling)
- Device class: 2
- Regulation: 21 CFR 868.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951094 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951094: Point-of-Care Arterial Blood Gas Monitoring System, Optical Sensors, Inc. (1996) Summary page 1.

## Indications for use
The modified SensiCath Sensor, when used as part of the Point-of-Care Blood gas Monitor System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients requiring an arterial pressure monitoring line. The ABG information is available to the attending qualified medical professional on demand and within approximately 60 seconds of the time the sample cycle was initiated. The intended use of the modified SensiCath Sensor is the same as the predicate SensiCath Sensor.

Source page: https://510kreport.com/device/K961790
Methodology: https://510kreport.com/methodology