Cleared Traditional

K871398 - CPU-1 INTENSIVE CARE VENTILATOR

K871398 is an FDA 510(k) clearance for CPU-1 INTENSIVE CARE 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 30-day FDA review.

K871398 · Ohmeda Medical · Anesthesiology device
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May 1987
Decision
30d
Days
Class 2
Risk

K871398 is an FDA 510(k) clearance for the CPU-1 INTENSIVE CARE 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 May 7, 1987 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohmeda Medical devices

FDA 510(k) Submission Details - K871398

510(k) Number K871398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date May 07, 1987
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 K871398.
SERVO VENTILATOR 900 C/D
K871354 · Siemens Elema AB · Jul 1987
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K871985 · Bear Medical Systems, Inc. · Jun 1987
PPG BIOMEDICAL VENTILATOR MODEL AV 400
K871433 · Ppg Industries, Inc. · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987
BIRD 6400ST VOLUME VENTILATOR
K863228 · Bird Products Corp. · Feb 1987
PEDIATRIC BELLOWS
K864431 · Draeger Medical, Inc. · Jan 1987