Cleared Traditional

K980642 - EVITA 4 (8411900)

K980642 is an FDA 510(k) clearance for EVITA 4 (8411900), 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 197-day FDA review.

K980642 · Drager, Inc. · Anesthesiology device
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Sep 1998
Decision
197d
Days
Class 2
Risk

K980642 is an FDA 510(k) clearance for the EVITA 4 (8411900). 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 September 4, 1998 after a review of 197 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 - K980642

510(k) Number K980642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1998
Decision Date September 04, 1998
Days to Decision 197 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
57d slower than avg
Panel avg: 140d · This submission: 197d
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 K980642.
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
K983981 · Bear Medical Systems, Inc. · Nov 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
BIRD MONITOR INTERFACE
K982580 · Bird Products Corp. · Oct 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
BABYLOG 8000 PLUS
K974176 · Drager, Inc. · Jun 1998