Cleared Special

K092135 - MODIFICATION TO IVENT 101

K092135 is an FDA 510(k) clearance for MODIFICATION TO IVENT 101, manufactured by Versamed Medical Systems , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 131-day FDA review.

K092135 · Versamed Medical Systems , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
131d
Days
Class 2
Risk

K092135 is an FDA 510(k) clearance for the MODIFICATION TO IVENT 101. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Versamed Medical Systems , Ltd. (Madison, US). The FDA issued a Cleared decision on November 23, 2009 after a review of 131 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092135

510(k) Number K092135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date November 23, 2009
Days to Decision 131 days
Submission Type Special
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
9d faster than avg
Panel avg: 140d · This submission: 131d
Pathway characteristics
Modification to existing cleared device.

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 435
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