Cleared Traditional

OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS (K950853) - FDA 510(k) Clearance

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

K950853 · Drager, Inc. · Anesthesiology device
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Nov 1996
Decision
617d
Days
Class 2
Risk

K950853 is an FDA 510(k) clearance for the OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS. 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 November 5, 1996 after a review of 617 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

Submission Details

510(k) Number K950853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 27, 1995
Decision Date November 05, 1996
Days to Decision 617 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
477d slower than avg
Panel avg: 140d · This submission: 617d
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 K950853.
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