Cleared Traditional

K880054 - CPU 1100 VENTILATOR

K880054 is an FDA 510(k) clearance for CPU 1100 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 98-day FDA review.

K880054 · Ohmeda Medical · Anesthesiology device
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Apr 1988
Decision
98d
Days
Class 2
Risk

K880054 is an FDA 510(k) clearance for the CPU 1100 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 98 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 - K880054

510(k) Number K880054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1988
Decision Date April 14, 1988
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K880054.
BEAR 3 VENTILATOR
K881335 · Bear Medical Systems, Inc. · Aug 1988
ADULT STAR
K872466 · Infrasonics Corp. · Jul 1988
MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · Puritan Bennett Corp. · May 1988
6400ST INTERFACE MODULE-RS232
K880721 · Bird Products Corp. · Apr 1988
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · Gambro, Inc. · Mar 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988