Cleared Traditional

K880054 - CPU 1100 VENTILATOR

K880054 is the FDA 510(k) clearance for CPU 1100 VENTILATOR by Ohmeda Medical. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 K880054.
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989
OHMEDA 7800 ANESTHESIA VENTILATOR
K883159 · Ohmeda Medical · Jun 1989
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