Cleared Traditional

K073694 - IVENT 2001 MRI CONDITIONAL

K073694 is an FDA 510(k) clearance for IVENT 2001 MRI CONDITIONAL, manufactured by Versamed Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K073694 · Versamed Medical Systems, Inc. · Anesthesiology device
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May 2008
Decision
151d
Days
Class 2
Risk

K073694 is an FDA 510(k) clearance for the IVENT 2001 MRI CONDITIONAL. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Versamed Medical Systems, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on May 30, 2008 after a review of 151 days - an extended review cycle.

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 Versamed Medical Systems, Inc. devices

FDA 510(k) Submission Details - K073694

510(k) Number K073694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2007
Decision Date May 30, 2008
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K073694.
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