510(k) · Cleared
ClearedBMD Air/Oxygen Blender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Devices, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Oct 7, 1993 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 7, 1993
- Review
- 316 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
- Descendant · cites it directly · 7 of its ownK053232 Precision BlenderPrecision Medical, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK090781 HELIO2 BlenderPrecision Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK081335 Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK221494 Quality Mix Blender, OxymixerDehas Medical Systems GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK142291 GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053232Precision BlenderPrecision Medical, Inc. · 2006 · cites it directly7descendants
- K090781HELIO2 BlenderPrecision Medical, Inc. · 2009 · 2 generations on2descendants
- K081335Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 2008 · cites it directly1descendant
- K221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH · 2023 · 2 generations on0descendants
- K142291GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925982 | BMD Air/Oxygen Blender | Biomedical Devices, Inc. | 1993 | — |
| +1 | K053232 | Precision Blender | Precision Medical, Inc. | 2006 | — |
| +2 | K090781 | HELIO2 Blender | Precision Medical, Inc. | 2009 | — |
| +1 | K081335 | Tenacore Oxygen Blender, Model TB-2000 | Tenacore Holdings, Inc. | 2008 | — |
| +2 | K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | 2023 | — |
| +2 | K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
3 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?
- Of its descendants, K053232 (Precision Medical, Inc., 2006) has gone furthest, with 7 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K925982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925982: BMD Air/Oxygen Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925982
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026