# K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Impact Instrumentation, Inc.
- Decided: Feb 16, 2012 after 265 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 65 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K103318: Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator, Impact Instrumentation, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- Apr 30, 2024 · Class I · Z-2130-2024: Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures sa
- 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.

## Indications for use
The devices in the Model 731 Ventilator Series are 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. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an “MRI conditional” label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are 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. The EMV+ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).

Source page: https://510kreport.com/device/K111473
Methodology: https://510kreport.com/methodology