510(k) · Cleared
ClearedMaxO2ME
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxtec, LLC · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jun 10, 2016 as substantially equivalent to K063096 (Precision Medical, Inc., 2007) after a 172-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 172 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911344 (1991). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911344 Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
- 1 generation backK063096 Precision Oxygen MonitorPrecision Medical, Inc. · 2007
- This deviceK153659 MaxO2MEMaxtec, LLC · 2016
- Descendant · cites it directly · 2 of its ownK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK251245 OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
- Descendant · cites it directly · 0 of its ownK213948 OxyMinderBio-Med Devices, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K221734Maxtec MaxO2 ME+pMaxtec, LLC · 2023 · cites it directly2descendants
- K251245OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025 · 2 generations on0descendants
- K231895Maxtec MaxBlend2+pMaxtec, LLC · 2023 · 2 generations on0descendants
- K213948OxyMinderBio-Med Devices, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | 1991 | — |
| −1 | K063096 | Precision Oxygen Monitor | Precision Medical, Inc. | 2007 | — |
| 0 (this device) | K153659 | MaxO2ME | Maxtec, LLC | 2016 | — |
| +1 | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| +2 | K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025 | — |
| +2 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
| +1 | K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221734 (Maxtec, LLC, 2023) has gone furthest, with 2 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. 2016, 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 MaxO2ME oxygen monitor is intended for continuous monitoring of the concentration of oxygen being delivered to patients ranging from newborns to adults. It can be used in the pre-hospital, hospital and sub-acute settings. The MaxO2ME is not intended as a life supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153659: MaxO2ME.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153659
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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