510(k) · Cleared
ClearedPrecision Oxygen Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Feb 27, 2007 as substantially equivalent to K911344 (Ceramatec, Inc., 1991) after a 140-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Feb 27, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911344 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK911344 Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
- This deviceK063096 Precision Oxygen MonitorPrecision Medical, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK153659 MaxO2MEMaxtec, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK251245 OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK213948 OxyMinderBio-Med Devices, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K153659MaxO2MEMaxtec, LLC · 2016 · cites it directly4descendants
- K221734Maxtec MaxO2 ME+pMaxtec, LLC · 2023 · 2 generations on2descendants
- K251245OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025 · 3 generations on0descendants
- K231895Maxtec MaxBlend2+pMaxtec, LLC · 2023 · 3 generations on0descendants
- K213948OxyMinderBio-Med Devices, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | 1991 | — |
| 0 (this device) | K063096 | Precision Oxygen Monitor | Precision Medical, Inc. | 2007 | — |
| +1 | K153659 | MaxO2ME | Maxtec, LLC | 2016 | — |
| +2 | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| +3 | K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025 | — |
| +3 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
| +2 | K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K911344 | Cerion Hand Held Oxygen AnalyzerSummary page 1…Class II PredicateDevice Equivalence Precision Medical, Inc. is claiming substantial equivalence to the Cerion Hand Held Oxygen Analyzer. Now (Maxtec) 510K number K911344 Device Description The Precision Medical, Inc. Oxygen monitor is a restricted medical device intended for use by… | 1991 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153659 | MaxO2ME | 2016 | 4 |
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?
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. 2007, this device’s year, is highlighted.
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?
The Precision Medical Oxygen Monitor is intended to measure the concentration of oxygen being delivered to the patient. The oxygen monitor is not intended as a life supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063096: Precision Oxygen Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063096
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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