# K963935: Olympus Critical Care Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Optical Sensors, Inc.
- Decided: Jan 23, 1997 after 114 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Cited in the summary but kept off the family tree
- K900598: Tramscope System, Marquette Electronics, Inc. (1990). Our OCR of the scanned summary read K900598, FDA’s number for Tramscope System (Marquette Electronics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Tram System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K984579: Capno Probe a (2000), 1 descendant of its own
- K212425: MicroTrend System (2024), 0 descendants of its own

## Indications for use
The Olympus System is intended to provide on-demand arterial blood gas monitoring in the operating room and at the bedside for critically ill patients with a pre-existing 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.

Source page: https://510kreport.com/device/K963935
Methodology: https://510kreport.com/methodology