Cleared Traditional

K883159 - OHMEDA 7800 ANESTHESIA VENTILATOR

K883159 is an FDA 510(k) clearance for OHMEDA 7800 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 316-day FDA review.

K883159 · Ohmeda Medical · Anesthesiology device
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Jun 1989
Decision
316d
Days
Class 2
Risk

K883159 is an FDA 510(k) clearance for the OHMEDA 7800 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 June 6, 1989 after a review of 316 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K883159

510(k) Number K883159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1988
Decision Date June 06, 1989
Days to Decision 316 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
176d slower than avg
Panel avg: 140d · This submission: 316d
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 K883159.
NEWPORT VENTILATOR MODEL E150
K883809 · Newport Medical Instruments, Inc. · Jun 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
STAR SYNC
K884521 · Infrasonics Corp. · Jun 1989
BEAR EVC-100 CONTROLLER
K882764 · Bear Medical Systems, Inc. · Sep 1988
PATIENT VENTILATOR ISOLATOR
K880923 · Dryden Corp. · Sep 1988
BEAR 3 VENTILATOR
K881335 · Bear Medical Systems, Inc. · Aug 1988