Cleared Traditional

K960964 - OHMEDA 7900 ANESTHESIA VENTILATOR

K960964 is the FDA 510(k) clearance for OHMEDA 7900 ANESTHESIA VENTILATOR by Ohmeda Medical. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 196
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K960964.
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K964543 · Nellcor Puritan Bennett, Inc. · Feb 1997
SERVO VENTILATOR 300 COMPUTER INTERFACE
K960010 · Siemens Elema AB · Oct 1996
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K960168 · Siemens Elema AB · Oct 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · Draeger Medical, Inc. · Mar 1996
MODEL 7200AE VENTILATOR
K922705 · Puritan Bennett Corp. · Sep 1994