Cleared Traditional

K960964 - OHMEDA 7900 ANESTHESIA VENTILATOR

K960964 is an FDA 510(k) clearance for OHMEDA 7900 ANESTHESIA VENTILATOR, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K960964 · Ohmeda Medical · Anesthesiology device
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Sep 1996
Decision
200d
Days
Class 2
Risk

K960964 is an FDA 510(k) clearance for the OHMEDA 7900 ANESTHESIA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 200 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K960964

510(k) Number K960964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 11, 1996
Decision Date September 27, 1996
Days to Decision 200 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
60d slower than avg
Panel avg: 140d · This submission: 200d
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 366
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K960964.
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K960861 · Core-M, Inc. · Aug 1996
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · Allied Healthcare Products, Inc. · Aug 1996