# K103318: Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Impact Instrumentation, Inc.
- Decided: Apr 7, 2011 after 146 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 64 ancestors in all.
5 later devices descend from it; 1 cites it directly.
7 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091238: Uni-Vent-731 Series Ventilators, Model 731EMV+, Impact Instrumentation, Inc. (2009) Summary page 3.

## Most influential descendants
- 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
- K122438: Hamilton-MR1 (2013), 1 descendant of its own
- K233486: 731 Series Ventilator (2024), 0 descendants of its own
- K153046: Hamilton-MR1 (2016), 0 descendants of its own

## Recalls of this device
- Jun 30, 2017 · Class II · Z-0812-2018: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
- Mar 19, 2012 · Class III · Z-2152-2012: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.

## Indications for use
The Model 731 EMV+ (EMV+) is indicated for use in the management of infant through adult patients weighing :5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. It is appropriate for use in hospitals, outside the hospital, during transport and in austere environments where it may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, it may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). It is not intended to operate in explosive environments. The EMV+ is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers.

Source page: https://510kreport.com/device/K103318
Methodology: https://510kreport.com/methodology