510(k) · Cleared
ClearedPrecision Blender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Jan 10, 2006 as substantially equivalent to K925982 (Biomedical Devices, Inc., 1993) after a 53-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it.
- Decided
- Jan 10, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925982 (1993). 7 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
- This deviceK053232 Precision BlenderPrecision Medical, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK090781 HELIO2 BlenderPrecision Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK221494 Quality Mix Blender, OxymixerDehas Medical Systems GmbH · 2023
- Descendant · cites it directly · 0 of its ownK142291 GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015
- Descendant · cites it directly · 0 of its ownK113232 Maxmixing BlockMaxtec, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K090781HELIO2 BlenderPrecision Medical, Inc. · 2009 · cites it directly2descendants
- K221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH · 2023 · cites it directly0descendants
- K142291GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015 · cites it directly0descendants
- K113232Maxmixing BlockMaxtec, Inc. · 2012 · cites it directly0descendants
- K111640Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925982 | BMD Air/Oxygen Blender | Biomedical Devices, Inc. | 1993 | — |
| 0 (this device) | K053232 | Precision Blender | Precision Medical, Inc. | 2006 | — |
| +1 | K090781 | HELIO2 Blender | Precision Medical, Inc. | 2009 | — |
| +1 | K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | 2023 | — |
| +1 | K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | 2015 | — |
| +1 | K113232 | Maxmixing Block | Maxtec, Inc. | 2012 | — |
| +1 | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K925982 | BMD Air/Oxygen BlenderSummary page 1…PM 5200 flow, range 2 to 120 liters per minute Predicate Device Equivalence Precision Medical, Inc. is claiming substantial equivalence to the Bio-Med Blender 510K # K925982 Device Description The Precision Medical, Inc. Air and Oxygen blender is a restricted medical device intended for use by qualif… | 1993 |
What descends from it? (7)
6 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?
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 | — |
What is it indicated for?
The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053232: Precision Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053232
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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