Cleared Traditional

EVITA 2 DURA (K970165) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970165 · Drager, Inc. · Anesthesiology device
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Aug 1997
Decision
222d
Days
Class 2
Risk

K970165 is an FDA 510(k) clearance for the EVITA 2 DURA. 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 August 26, 1997 after a review of 222 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

Submission Details

510(k) Number K970165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 16, 1997
Decision Date August 26, 1997
Days to Decision 222 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 140d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 110
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K970165.
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 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
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
MODEL 7200AE VENTILATOR
K922705 · Puritan Bennett Corp. · Sep 1994
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K922975 · Puritan Bennett Corp. · Sep 1994