Cleared Traditional

K091238 - UNI-VENT-731 SERIES VENTILATORS

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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K091238.
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
HAMILTON-C2
K092148 · Hamilton Medical AG · Mar 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
HAMILTON-C2
K090468 · Hamilton Medical AG · Jun 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · Fisher &Paykel Healthcare , Ltd. · Mar 2009
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · Impact Instrumentation, Inc. · Dec 2008