510(k) · Cleared

Cleared

Olympus Critical Care Monitoring System

K963935510(k) TraditionalCleared Jan 23, 1997114-day reviewClass II21 CFR 868.1150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Optical Sensors, Inc. · CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

Cleared on Jan 23, 1997 as substantially equivalent to K951094 (Optical Sensors, Inc., 1996) after a 114-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided: Jan 23, 1997
Review: 114 days
Class: Class II
Product code: CCC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951094 (1996). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK951094 Point-of-Care Arterial Blood Gas Monitoring SystemOptical Sensors, Inc. · 1996
This deviceK963935 Olympus Critical Care Monitoring SystemOptical Sensors, Inc. · 1997
Descendant · cites it directly · 1 of its ownK984579 Capno Probe aOptical Sensors, Inc. · 2000
Descendant · 2 generations on · 0 of its ownK212425 MicroTrend SystemExostat Medical, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all

K984579Capno Probe aOptical Sensors, Inc. · 2000 · cites it directly1descendant
K212425MicroTrend SystemExostat Medical, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951094	Point-of-Care Arterial Blood Gas Monitoring System	Optical Sensors, Inc.	1996	—
0 (this device)	K963935	Olympus Critical Care Monitoring System	Optical Sensors, Inc.	1997	—
+1	K984579	Capno Probe a	Optical Sensors, Inc.	2000	—
+2	K212425	MicroTrend System	Exostat Medical, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2024	1	0

FIG. 1 — Lineage of K963935, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K951094	Point-of-Care Arterial Blood Gas Monitoring System Summary page 1 …Monitor. Trade Name: Olympus Critical Care Monitoring System. Classification Name: Blood Gas Monitor. Predicate Device: Point-of-Care Blood Gas Monitor System 510(k) K951094 Tram® System 510(k) K900598 4.1.1 DESCRIPTION OF THE DEVICE It is the intention of Optical Sensors Incorporated (OSI) to intro…	Optical Sensors, Inc.	1996	—
Kept off the family tree	K900598	FDA’s K900598 is Tramscope System 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 …Critical Care Monitoring System. Classification Name: Blood Gas Monitor. Predicate Device: Point-of-Care Blood Gas Monitor System 510(k) K951094 Tram® System 510(k) K900598 4.1.1 DESCRIPTION OF THE DEVICE It is the intention of Optical Sensors Incorporated (OSI) to introduce into commercial distribu…	Marquette Electronics, Inc.	1990	—

Also cleared against K951094: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K984579	Capno Probe a	Optical Sensors, Inc.	2000	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K984579 (Optical Sensors, Inc., 2000) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K951094.

How does its category compare?

All CCC devices

CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCC

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCC

Too few CCC 510(k)s in any year since 2007 to give a median.

Recalls per year · CCC

No recall names CCC since 2007.

Adverse event reports per year · CCC

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code CCC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963935 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963935: Olympus Critical Care Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963935

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026