510(k) · Cleared
ClearedMaxtec MaxO2 ME+p
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 Apr 1, 2023 as substantially equivalent to K153659 (Maxtec, LLC, 2016) and 1 other predicate after a 290-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 1, 2023
- Review
- 290 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911344 (1991). 8 ancestors in all, the oldest K871083 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK911344 Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
- 2 generations backK063096 Precision Oxygen MonitorPrecision Medical, Inc. · 2007
- 1 generation backK153659 MaxO2MEMaxtec, LLC · 2016
- This deviceK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- Descendant · cites it directly · 0 of its ownK251245 OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | 1991 | — |
| −2 | K063096 | Precision Oxygen Monitor | Precision Medical, Inc. | 2007 | — |
| −1 | K153659 | MaxO2ME | Maxtec, LLC | 2016 | — |
| 0 (this device) | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| +1 | K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025 | — |
| +1 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1993 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K153659 | MaxO2MESummary page 4…Classification Code: CAP Classification Name: Monitor, Airway Pressure Primary Predicate Device: Maxtec – MaxO2 ME - K153659 Secondary Predicate Device: Caradyne – Criterion 40 - K992101 Device Description: The MaxO2 ME +p is a battery power… | 2016 |
| * | K992101 | Criterion 40 or PM 40Summary page 4…Monitor, Airway Pressure Primary Predicate Device: Maxtec – MaxO2 ME - K153659 Secondary Predicate Device: Caradyne – Criterion 40 - K992101 Device Description: The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor me… | 2000 |
What descends from it? (2)
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 32 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K251245 (Bio-Med Device, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153659.
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. 2023, 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 MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221734: Maxtec MaxO2 ME+p.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221734
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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