510(k) Report

510(k) · Cleared

Cleared

Point-of-Care Arterial Blood Gas Monitoring System

K951094510(k) TraditionalCleared Jan 16, 1996313-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 16, 1996 after a 313-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jan 16, 1996
Review
313 days
Class
Class II
Product code
CCC
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2000: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951094 Point-of-Care Arterial Blood Gas Monitoring SystemOptical Sensors, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK963935 Olympus Critical Care Monitoring SystemOptical Sensors, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK984579 Capno Probe aOptical Sensors, Inc. · 2000
  4. Descendant · 2 generations on · 0 of its ownK212425 MicroTrend SystemExostat Medical, Inc. · 2024
  5. Descendant · cites it directly · 0 of its ownK961790 Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc. · 1997

Most influential descendants

Showing 4 of 4 · See all
  • K963935Olympus Critical Care Monitoring SystemOptical Sensors, Inc. · 1997 · cites it directly2descendants
  • K984579Capno Probe aOptical Sensors, Inc. · 2000 · cites it directly1descendant
  • K212425MicroTrend SystemExostat Medical, Inc. · 2024 · 2 generations on0descendants
  • K961790Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951094Point-of-Care Arterial Blood Gas Monitoring SystemOptical Sensors, Inc.1996—
+1K963935Olympus Critical Care Monitoring SystemOptical Sensors, Inc.1997—
+1K984579Capno Probe aOptical Sensors, Inc.2000—
+2K212425MicroTrend SystemExostat Medical, Inc.2024—
+1K961790Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200010
202410
FIG. 1 — Lineage of K951094, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963935Olympus Critical Care Monitoring SystemOptical Sensors, Inc.19972
K984579Capno Probe aOptical Sensors, Inc.20001
K961790Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc.19970

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?

  • Of its descendants, K963935 (Optical Sensors, Inc., 1997) has gone furthest, with 2 descendants of its own.

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

2007: 1
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

2007: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Optical Sensors, Inc.

7 FDA decisions under this applicant name. See the company

  • K040654Sensilase Pad 3000Optical Sensors, Inc. · 2004
  • K010795Capnoprobe SL, Model 2000Optical Sensors, Inc. · 20011 recall
  • K984579Capno Probe aOptical Sensors, Inc. · 2000
  • K961790Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc. · 1997
  • K963935Olympus Critical Care Monitoring SystemOptical Sensors, Inc. · 1997

Recent decisions in CCC

The CCC category page

  • K071165Iscalert Sensor SystemAlertis Medical AS · 2007
  • K983198Trendcare Calibrator Model Scu 7007Diametrics Medical, Ltd. · 1999
  • K972314Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor SystemDiametrics Medical, Ltd. · 1997
  • K953893Paratrend 7 Intravascular Blood Gas Monitoring SystemBiomedical Sensors, Inc. · 1997
  • K961790Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc. · 1997

https://510kreport.com/device/K951094 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951094: Point-of-Care Arterial Blood Gas Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951094

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026