510(k) · Cleared
ClearedUni-Vent Model 730AEV (Automatic Emergency Ventilator)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impact Instrumentation, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Mar 26, 2004 as substantially equivalent to K861272 (Impact Instrumentation, Inc., 1986) and 3 other predicates after a 235-day review. Its family tree reaches back 2 generations to 1995. 3 of the 15 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 235 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K943531 (1995). 6 ancestors in all, the oldest K861272 (1986). 8 later devices descend from it, 1 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK943531 Oxylog 2000Drager, Inc. · 1995
- 1 generation backK981668 Smartvent 201 Portable VentilatorVersamed, Ltd. · 1999
- This deviceK032386 Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK071526 Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 5 of its ownK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 4 of its ownK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 1 of its ownK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · cites it directly7descendants
- K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · 2 generations on6descendants
- K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · 3 generations on5descendants
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 4 generations on4descendants
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943531 | Oxylog 2000 | Drager, Inc. | 1995 | — |
| −1 | K981668 | Smartvent 201 Portable Ventilator | Versamed, Ltd. | 1999 | — |
| 0 (this device) | K032386 | Uni-Vent Model 730AEV (Automatic Emergency Ventilator) | Impact Instrumentation, Inc. | 2004 | — |
| +1 | K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | Impact Instrumentation, Inc. | 2008 | 1 |
| +2 | K091238 | Uni-Vent-731 Series Ventilators, Model 731EMV+ | Impact Instrumentation, Inc. | 2009 | 1 |
| +3 | K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2011 | 2 |
| +4 | K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2012 | Class I |
| +5 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 1 |
| 2024 | 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.
3 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K861272 | Impact Models 701, 702 and 703Summary page 1…assification: Class II Product Code: BTL Predicate Devices: 1. Impact Models 701, 702, 703. 5 10(k) #K861272/A. 2. Uni-Vent- MinuteVolume Ventilator, Model 750.… | 1986 |
| * | K870861 | Uni-Vent (TM) Impact Minute Volume VentilatorSummary page 1…703. 5 10(k) #K861272/A. 2. Uni-Vent- MinuteVolume Ventilator, Model 750. 510(k) #K870861/B. 3. Uni-Vent- Eagle, Model 754. 510(k) #K870861/B… | 1988 |
| * | K931473 | Impact Model 753Summary page 1…510(k) #K870861/B. 3. Uni-Vent- Eagle, Model 754. 510(k) #K870861/B and K931473. 4. Smartvent 201 (CBK) Portable Ventilator.… | 1994 |
| * | K981668 | Smartvent 201 Portable VentilatorSummary page 1…and K931473. 4. Smartvent 201 (CBK) Portable Ventilator. 5 10(k) #K981668 6-i… | 1999 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | 2008 | 7 |
Has anything in its family been recalled? (3 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.
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071526 (Impact Instrumentation, Inc., 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Model 730 AEV TM is intended to provide continuous ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. It is appropriate for use with adults and children- in clinical, field hospital, transport, aeromedical and pre-hospital (BLS through ATLS) environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032386: Uni-Vent Model 730AEV (Automatic Emergency Ventilator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032386
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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