510(k) · Cleared
ClearedHeliox Low Flow Sentry Blender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 207, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Apr 2, 2010 as substantially equivalent to K911962 (Bird Products Corp., 1991) and 2 other predicates after a 232-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Apr 2, 2010
- Review
- 232 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K925982 (1993). 5 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
- 2 generations backK053232 Precision BlenderPrecision Medical, Inc. · 2006
- 1 generation backK090781 HELIO2 BlenderPrecision Medical, Inc. · 2009
- This deviceK092484 Heliox Low Flow Sentry BlenderCardinal Health 207, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925982 | BMD Air/Oxygen Blender | Biomedical Devices, Inc. | 1993 | — |
| −2 | K053232 | Precision Blender | Precision Medical, Inc. | 2006 | — |
| −1 | K090781 | HELIO2 Blender | Precision Medical, Inc. | 2009 | — |
| 0 (this device) | K092484 | Heliox Low Flow Sentry Blender | Cardinal Health 207, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 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? (3)
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 |
|---|---|---|---|
| * | K911962 | Bird Sentry Air/Oxygen MicroblenderSummary page 1…73 BZR 21 CFR 868.5330 Anesthesiologyd Predicate Device: The predicate devices are: Sentry air/oxygen microblendler (K911962) Low Flow air/oxygen blender (K883038) Helio2 Blender (K(090781) Device Description: The h… | 1991 |
| * | K883038 | P/N 9320 Low Flow Air/Oxygen MicroblenderSummary page 1…esthesiologyd Predicate Device: The predicate devices are: Sentry air/oxygen microblendler (K911962) Low Flow air/oxygen blender (K883038) Helio2 Blender (K(090781) Device Description: The helium/oxygen and oxygen blender/monitor combines a precis… | 1988 |
| * | K090781 | HELIO2 BlenderSummary page 1…e devices are: Sentry air/oxygen microblendler (K911962) Low Flow air/oxygen blender (K883038) Helio2 Blender (K(090781) Device Description: The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%//2… | 2009 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K911962.
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. 2010, 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 Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen
gas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an
79% Helium / 21 % Oxygen gas source with a 100% oxygen gas source to provide low
flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium
for patients who are spontaneously breathing. It is a medical device intended for use by
qualified, trained personnel, under the direction of a physician, in institutional
environments where the delivery and monitoring of helium/oxygen mixture is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092484: Heliox Low Flow Sentry Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092484
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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