# K032386: Uni-Vent Model 730AEV (Automatic Emergency Ventilator)

- Pathway: 510(k) (Traditional)
- Applicant: Impact Instrumentation, Inc.
- Decided: Mar 26, 2004 after 235 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943531 (1995). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861272: Impact Models 701, 702 and 703, Impact Instrumentation, Inc. (1986) Summary page 1.
- K870861: Uni-Vent (TM) Impact Minute Volume Ventilator, Impact Instrumentation, Inc. (1988) Summary page 1.
- K931473: Impact Model 753, Impact Instrumentation, Inc. (1994) Summary page 1.
- K981668: Smartvent 201 Portable Ventilator, Versamed, Ltd. (1999) Summary page 1.

## Most influential descendants
- K071526: Uni-Vent 731 Series Ventilators, Model 731, 731EMV (2008), 7 descendants of its own
- K091238: Uni-Vent-731 Series Ventilators, Model 731EMV+ (2009), 6 descendants of its own
- K103318: Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator (2011), 5 descendants of its own
- K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator (2012), 4 descendants of its own
- K162832: 731 Series Ventilators (2017), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032386
Methodology: https://510kreport.com/methodology