510(k) · Cleared
ClearedDowns Cap Flow Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Jun 9, 1981 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Jun 9, 1981
- Review
- 22 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- This deviceK811393 Downs Cap Flow GeneratorVital Signs, Inc. · 1981
- Descendant · cites it directly · 14 of its ownK982283 Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500…Caradyne, Ltd. · 1999
- Descendant · 2 generations on · 7 of its ownK080692 Macs Cpap SystemAiron Corporation · 2008
- Descendant · 3 generations on · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK013884 Boussignac C.P.a.P. DeviceVygon SA · 2003
- Descendant · 4 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123957 Pneupac Parapac Plus3 generations on · 2013
Most influential descendants
Showing 5 of 15 · See all- K982283Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow…Caradyne, Ltd. · 1999 · cites it directly14descendants
- K080692Macs Cpap SystemAiron Corporation · 2008 · 2 generations on7descendants
- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · 3 generations on4descendants
- K013884Boussignac C.P.a.P. DeviceVygon SA · 2003 · 2 generations on4descendants
- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811393 | Downs Cap Flow Generator | Vital Signs, Inc. | 1981 | — |
| +1 | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow… | Caradyne, Ltd. | 1999 | — |
| +2 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| +3 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +2 | K013884 | Boussignac C.P.a.P. Device | Vygon SA | 2003 | — |
| +4 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 3 | 1 |
| 2014 | 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.
1 device in this family has 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? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow… | 1999 | 14 |
Has anything in its family been recalled? (1 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.
- K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 16 Class I recalls
What does this lineage say?
- Of its descendants, K982283 (Caradyne, Ltd., 1999) has gone furthest, with 14 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/K811393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K811393: Downs Cap Flow Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811393
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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