510(k) · Cleared
ClearedVentrex Oxygen Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventrex, LLC · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Nov 25, 1996 as substantially equivalent to K862113 (Vascular Technology Incorporated, 1986) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Nov 25, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862113 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862113 NO. 100352 Galvanic Oxygen SensorVascular Technology Incorporated · 1986
- This deviceK963415 Ventrex Oxygen SensorVentrex, LLC · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862113 | NO. 100352 Galvanic Oxygen Sensor | Vascular Technology Incorporated | 1986 | — |
| 0 (this device) | K963415 | Ventrex Oxygen Sensor | Ventrex, LLC | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
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 CCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862113 | NO. 100352 Galvanic Oxygen SensorSummary page 1…or Proprietary or Trade Name. VENTREX OXYGEN SENSOR Common/Usual Name: Oxygen Sensor Intended Device: Oxygen Sensor Predicate Device: Vascular Technology Oxygen Sensors K862113 Seatronics Oxygen Sensors K953351 Device Description: The VENTREX line of oxygen sensors are medical devices which produce an e… | 1986 |
| * | K953351 | Seatronics Family of Galvanic Oxygen SensorsSummary page 1…REX OXYGEN SENSOR Common/Usual Name: Oxygen Sensor Intended Device: Oxygen Sensor Predicate Device: Vascular Technology Oxygen Sensors K862113 Seatronics Oxygen Sensors K953351 Device Description: The VENTREX line of oxygen sensors are medical devices which produce an electrical current which is directl… | 1995 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Each is used to determine the amount (expressed as % O, ) of oxygen present in an atmosphere.
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/K963415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963415: Ventrex Oxygen Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963415
Report an extraction error
Are you the manufacturer?
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