510(k) · Cleared
ClearedHELIO2 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 Aug 13, 2009 as substantially equivalent to K053232 (Precision Medical, Inc., 2006) after a 143-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 13, 2009
- Review
- 143 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925982 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
- 1 generation backK053232 Precision BlenderPrecision Medical, Inc. · 2006
- This deviceK090781 HELIO2 BlenderPrecision Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK092484 Heliox Low Flow Sentry BlenderCardinal Health 207, Inc. · 2010
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 | K925982 | BMD Air/Oxygen Blender | Biomedical Devices, Inc. | 1993 | — |
| −1 | K053232 | Precision Blender | Precision Medical, Inc. | 2006 | — |
| 0 (this device) | K090781 | HELIO2 Blender | Precision Medical, Inc. | 2009 | — |
| +1 | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | 1 |
| +1 | K092484 | Heliox Low Flow Sentry Blender | Cardinal Health 207, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K053232 | Precision BlenderSummary page 1…5470/5480 flow, range 2 to 30 liters per minute High flow blender PM 5580/5570 flow, range 15 to 120 liters per minute Predicate Device Equivalence 510OK#4 K053232 Precision Medical, Inc. is claiming substantial to Precision Medical, Inc. oxygen blender same as… | 2006 |
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 16 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111640 (Vapotherm, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K053232.
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. 2009, 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 Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.
The blender is not intended as a life supporting device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090781: HELIO2 Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090781
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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