510(k) · Cleared
ClearedMaxBlend 2, MaxBlend Lite
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 Oct 27, 2016 as substantially equivalent to K973646 (Bird Products Corp., 1998) after a 127-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Oct 27, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883038 (1988). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK883038 P/N 9320 Low Flow Air/Oxygen MicroblenderBird Products Corp. · 1988
- 1 generation backK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
- This deviceK161718 MaxBlend 2, MaxBlend LiteMaxtec, LLC · 2016
- Descendant · cites it directly · 0 of its ownK243917 F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd. · 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 |
|---|---|---|---|---|---|
| −2 | K883038 | P/N 9320 Low Flow Air/Oxygen Microblender | Bird Products Corp. | 1988 | — |
| −1 | K973646 | Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer | Bird Products Corp. | 1998 | — |
| 0 (this device) | K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | 2016 | — |
| +1 | K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
| +1 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K973646 | Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerSummary page 4…Code: BZR, Class II Additional Product Code: CCL, Class II Predicate Device: Bird, Sentry Blender – K973646 Reference Devices: K153659 – Maxtec MaxO2ME K883038 – CareFusio… | 1998 |
| † | K153659 | MaxO2ME | 2016 |
| † | K883038 | P/N 9320 Low Flow Air/Oxygen Microblender | 1988 |
| † | K925982 | BMD Air/Oxygen Blender | 1993 |
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 28 years and passes through 2 companies; a new generation was cleared every 18.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K243917 (Fisher & Paykel Healthcare, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K973646.
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. 2016, 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 MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen 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, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161718: MaxBlend 2, MaxBlend Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161718
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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