Cleared Traditional

K974176 - BABYLOG 8000 PLUS

K974176 is an FDA 510(k) clearance for BABYLOG 8000 PLUS, 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 223-day FDA review.

K974176 · Drager, Inc. · Anesthesiology device
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Jun 1998
Decision
223d
Days
Class 2
Risk

K974176 is an FDA 510(k) clearance for the BABYLOG 8000 PLUS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager, Inc. (Telford, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 223 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 Drager, Inc. devices

FDA 510(k) Submission Details - K974176

510(k) Number K974176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1997
Decision Date June 17, 1998
Days to Decision 223 days
Submission Type Traditional
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
83d slower than avg
Panel avg: 140d · This submission: 223d
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 K974176.
EVITA 4 (8411900)
K980642 · Drager, Inc. · Sep 1998
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
K981971 · Bird Products Corp. · Aug 1998
DIVAN ANESTHESIA VENTILATOR
K980208 · Draeger Medical, Inc. · Aug 1998
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K970460 · Puritan Bennett Corp. · Apr 1998
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · Puritan Bennett Corp. · Nov 1997
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
K972203 · Allied Healthcare Products, Inc. · Nov 1997