510(k) · Cleared
ClearedCerion Hand Held Oxygen Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceramatec, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jun 18, 1991 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 of the 132 devices in its family, counting itself, have a Class I recall. 131 later devices descend from it.
- Decided
- Jun 18, 1991
- Review
- 83 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
131 later devices descend from it, 2 citing it directly. 38 of the 132 devices in this family, counting this one, have a Class I recall.
- This deviceK911344 Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
- Descendant · cites it directly · 125 of its ownK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
- Descendant · 2 generations on · 120 of its ownK020746 Bird Tbird Vela VentilatorBird Products Corp. · 2002
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 131 · See all- K973646Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998 · cites it directly125descendants
- K020746Bird Tbird Vela VentilatorBird Products Corp. · 2002 · 2 generations on120descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | 1991 | — |
| +1 | K973646 | Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer | Bird Products Corp. | 1998 | — |
| +2 | K020746 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2002 | — |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 1 |
| 2008 | 6 | 1 |
| 2009 | 5 | 1 |
| 2010 | 3 | 1 |
| 2011 | 12 | 7 |
| 2012 | 14 | 5 |
| 2013 | 10 | 4 |
| 2014 | 5 | 1 |
| 2015 | 7 | 1 |
| 2016 | 8 | 2 |
| 2017 | 10 | 4 |
| 2018 | 2 | 0 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2022 | 2 | 0 |
| 2023 | 4 | 1 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
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.
38 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (131)
See all 1312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (38 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 38 shown.
Nearest 5 of 38; all are on the web page.
What does this lineage say?
- Of its descendants, K973646 (Bird Products Corp., 1998) has gone furthest, with 125 descendants of its own.
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 | — |
https://510kreport.com/device/K911344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911344: Cerion Hand Held Oxygen Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911344
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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