Cleared Traditional

K902084 - OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE

K902084 is an FDA 510(k) clearance for OHMEDA 7800 ANESTHESIA VENTILATOR SOFTW..., 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 146-day FDA review.

K902084 · Ohmeda Medical · Anesthesiology device
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Oct 1990
Decision
146d
Days
Class 2
Risk

K902084 is an FDA 510(k) clearance for the OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE. 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 October 1, 1990 after a review of 146 days - within the typical 510(k) review window.

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 - K902084

510(k) Number K902084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date October 01, 1990
Days to Decision 146 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
6d slower than avg
Panel avg: 140d · This submission: 146d
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 K902084.
AIROX AXR. 1A
K901953 · Ferguson Medical · Jan 1991
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · Aequitron Medical, Inc. · Nov 1990
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · Aequitron Medical, Inc. · Nov 1990
NEWPORT WAVE VENTILATOR MODEL E200
K901785 · Newport Medical Instruments, Inc. · Aug 1990
BEAR CEM CONTROLLER
K900637 · Bear Medical Systems, Inc. · Aug 1990
SECHRIST VOLUME VENTILATOR MODEL 2200B
K896269 · Sechrist Industries, Inc. · May 1990