510(k) · Cleared
ClearedMaxtec MaxBlend2+p
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxtec, LLC · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Dec 4, 2023 as substantially equivalent to K161718 (Maxtec, LLC, 2016) and 1 other predicate after a 159-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Dec 4, 2023
- Review
- 159 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911344 (1991). 13 ancestors in all, the oldest K871083 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK911344 Cerion Hand Held Oxygen AnalyzerCeramatec, Inc. · 1991
- 3 generations backK063096 Precision Oxygen MonitorPrecision Medical, Inc. · 2007
- 2 generations backK153659 MaxO2MEMaxtec, LLC · 2016
- 1 generation backK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- This deviceK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911344 | Cerion Hand Held Oxygen Analyzer | Ceramatec, Inc. | 1991 | — |
| −3 | K063096 | Precision Oxygen Monitor | Precision Medical, Inc. | 2007 | — |
| −2 | K153659 | MaxO2ME | Maxtec, LLC | 2016 | — |
| −1 | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| 0 (this device) | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2016 | 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 BZR? 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 BZR device
- #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 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 |
|---|---|---|---|
| * | K161718 | MaxBlend 2, MaxBlend LiteSummary page 5…fication Code: CAP Classification Name: Monitor, Airway Pressure Predicate Device: Maxtec MaxBlend 2 - K161718 Secondary Predicate: MaxO2ME+p -K221734 Device Description: The Maxtec MaxBlend 2+p is an oxygen delivery d… | 2016 |
| * | K221734 | Maxtec MaxO2 ME+pSummary page 5…Monitor, Airway Pressure Predicate Device: Maxtec MaxBlend 2 - K161718 Secondary Predicate: MaxO2ME+p -K221734 Device Description: The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery power… | 2023 |
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?
- 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 13 ancestors has a recall.
- 1 other device also cites its predicate K161718.
How does its category compare?
All BZR devicesBZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · BZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZR
203in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZR
No recall names BZR since 2007.
Adverse event reports per year · BZR
13in 2025
MAUDE reports naming product code BZR, 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 | 0 | — | 0 | 15 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 2 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 1 | — | 0 | 39 |
| 2016 | 1 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 4 | 203 | 0 | 19 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the
concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical
device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare
settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is
required.
This 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/K231895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231895: Maxtec MaxBlend2+p.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231895
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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