Cleared Traditional

K091238 - UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+

K091238 is an FDA 510(k) clearance for UNI-VENT-731 SERIES VENTILATORS, manufactured by Impact Instrumentation, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K091238 · Impact Instrumentation, Inc. · Anesthesiology device
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Aug 2009
Decision
108d
Days
Class 2
Risk

K091238 is an FDA 510(k) clearance for the UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 13, 2009 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impact Instrumentation, Inc. devices

FDA 510(k) Submission Details - K091238

510(k) Number K091238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date August 13, 2009
Days to Decision 108 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 140d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 422
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K091238.
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
K092264 · Providence Global Medical, Inc. · Dec 2009
MODIFICATION TO IVENT 101
K092135 · Versamed Medical Systems , Ltd. · Nov 2009
NEWPORT HT70 FAMILY OF VENTILATORS
K090888 · Newport Medical Instruments, Inc. · Nov 2009
HAMILTON-C2
K090468 · Hamilton Medical AG · Jun 2009
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
K083693 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Apr 2009
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
K083688 · Pulmonetic Systems, Inc. · Mar 2009