510(k) · Cleared
ClearedPoint-of-Care Blood Gas Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optical Sensors, Inc. · CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Cleared on Apr 9, 1997 as substantially equivalent to K951094 (Optical Sensors, Inc., 1996) after a 335-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 9, 1997
- Review
- 335 days
- Class
- Class II
- Product code
- CCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951094 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK951094 Point-of-Care Arterial Blood Gas Monitoring SystemOptical Sensors, Inc. · 1996
- This deviceK961790 Point-of-Care Blood Gas Monitor SystemOptical Sensors, Inc. · 1997
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) | K961790 | Point-of-Care Blood Gas Monitor System | Optical Sensors, Inc. | 1997 | — |
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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951094 | Point-of-Care Arterial Blood Gas Monitoring SystemSummary page 1…ndwelling blood hydrogen ion concentration (pH) analyzer. e 73 CCE 21 CFR 868.1200 Indwelling blood oxygen partial Predicate Device: pressure (PO;) analyzer. 510(k) K95 1094 SensiCath ™ Point-of-Care Blood Gas Monitor System 10 7615 GoPOPR TriancLe Dr. TECHNOLOGY Park Five MiNNEAPOLIS, MN 55344 PHONE… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 other devices also cite its predicate K951094.
How does its category compare?
All CCC devicesCCC 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
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
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/K961790 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961790: Point-of-Care Blood Gas Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961790
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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