Cleared Traditional

K903089 - BABYLOG 8000 INFANT VENTILATOR

K903089 is an FDA 510(k) clearance for BABYLOG 8000 INFANT VENTILATOR, 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 332-day FDA review.

K903089 · Drager, Inc. · Anesthesiology device
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Jun 1991
Decision
332d
Days
Class 2
Risk

K903089 is an FDA 510(k) clearance for the BABYLOG 8000 INFANT VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 332 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Drager, Inc. devices

FDA 510(k) Submission Details - K903089

510(k) Number K903089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1990
Decision Date June 10, 1991
Days to Decision 332 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
192d slower than avg
Panel avg: 140d · This submission: 332d
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 K903089.
BIRD NEBULIZATION SYNCHRONIZER
K911336 · Bird Products Corp. · Nov 1991
VENTILATOR STAND
K914485 · Bird Products Corp. · Oct 1991
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · Mallinckrodt Medical · Mar 1991
ADULT STAR, MODIFICATION
K905272 · Infrasonics Corp. · Jan 1991