Cleared Traditional

K953238 - DRAGER MICRO VENT

K953238 is an FDA 510(k) clearance for DRAGER MICRO VENT, manufactured by Drager, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 433-day FDA review.

K953238 · Drager, Inc. · Anesthesiology device
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Sep 1996
Decision
433d
Days
Class 2
Risk

K953238 is an FDA 510(k) clearance for the DRAGER MICRO VENT. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager, Inc. (Chantilly, US). The FDA issued a Cleared decision on September 16, 1996 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Drager, Inc. devices

FDA 510(k) Submission Details - K953238

510(k) Number K953238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 11, 1995
Decision Date September 16, 1996
Days to Decision 433 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
293d slower than avg
Panel avg: 140d · This submission: 433d
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 318
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K953238.
SERVO VENTILATOR 300 COMPUTER INTERFACE
K960010 · Siemens Elema AB · Oct 1996
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K960168 · Siemens Elema AB · Oct 1996
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
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