510(k) · Cleared
ClearedP/N 9320 Low Flow Air/Oxygen Microblender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bird Products Corp. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Nov 16, 1988 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 of the 128 devices in its family, counting itself, have a Class I recall. 127 later devices descend from it.
- Decided
- Nov 16, 1988
- Review
- 120 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 0
127 later devices descend from it, 2 citing it directly. 38 of the 128 devices in this family, counting this one, have a Class I recall.
- This deviceK883038 P/N 9320 Low Flow Air/Oxygen MicroblenderBird Products Corp. · 1988
- Descendant · cites it directly · 125 of its ownK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
- Descendant · 2 generations on · 120 of its ownK020746 Bird Tbird Vela VentilatorBird Products Corp. · 2002
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 127 · See all- K973646Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998 · cites it directly125descendants
- K020746Bird Tbird Vela VentilatorBird Products Corp. · 2002 · 2 generations on120descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K020746 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2002 | — |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 1 |
| 2008 | 6 | 1 |
| 2009 | 5 | 1 |
| 2010 | 4 | 1 |
| 2011 | 12 | 7 |
| 2012 | 14 | 5 |
| 2013 | 10 | 4 |
| 2014 | 5 | 1 |
| 2015 | 7 | 1 |
| 2016 | 7 | 2 |
| 2017 | 10 | 4 |
| 2018 | 2 | 0 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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.
38 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (127)
See all 1272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (38 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 38 shown.
Nearest 5 of 38; all are on the web page.
What does this lineage say?
- Of its descendants, K973646 (Bird Products Corp., 1998) has gone furthest, with 125 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/K883038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883038: P/N 9320 Low Flow Air/Oxygen Microblender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883038
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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