Cleared Traditional

K953228 - NARKOMED AV2+ ANESTHESIA VENTILATOR

K953228 is an FDA 510(k) clearance for NARKOMED AV2+ ANESTHESIA VENTILATOR, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K953228 · Draeger Medical, Inc. · Anesthesiology device
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Mar 1996
Decision
235d
Days
Class 2
Risk

K953228 is an FDA 510(k) clearance for the NARKOMED AV2+ ANESTHESIA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 235 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K953228

510(k) Number K953228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 10, 1995
Decision Date March 01, 1996
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 140d · This submission: 235d
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 K953228.
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · Allied Healthcare Products, Inc. · Aug 1996
MODEL LP-1000 VOLUME VENTILATOR
K952880 · Aequitron Medical, Inc. · Jun 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996
MODEL 7200AE VENTILATOR
K922705 · Puritan Bennett Corp. · Sep 1994
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K922975 · Puritan Bennett Corp. · Sep 1994
AUTO-PEEP
K924043 · Puritan Bennett Corp. · Sep 1994