UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR— 510(k) K103318

Clearance details

Applicant

Impact Instrumentation, Inc.

Product code

Code CBK

Device class

Class 2

Regulation

21 CFR 868.5895

Advisory panel

Anesthesiology

Date received

2010-11-12

Decision date

2011-04-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Caldwell, NJ, US

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• K133196 — IMPACT MODEL 323 ASPIRATOR2014-03-10
• K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR2012-02-16
• K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+2009-08-13
• K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV2008-12-10
• K051476 — UNI-VENT MODEL 73X2005-10-28

Death

736

Injury

3,628

Malfunction

98,786

Other

4

Total

103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0812-2018 — 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator 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 severe 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. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The 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 with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,Class II·Terminated·ZOLL Medical Corporation·20170630
• Z-2152-2012 — Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.Class III·Terminated·Impact Instrumentation, Inc.·20120319

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103318.