Cleared Traditional

K864431 - PEDIATRIC BELLOWS

K864431 is an FDA 510(k) clearance for PEDIATRIC BELLOWS, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K864431 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
61d
Days
Class 2
Risk

K864431 is an FDA 510(k) clearance for the PEDIATRIC BELLOWS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 61 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K864431

510(k) Number K864431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date January 12, 1987
Days to Decision 61 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
79d faster than avg
Panel avg: 140d · This submission: 61d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K864431.
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987
BIRD 6400ST VOLUME VENTILATOR
K863228 · Bird Products Corp. · Feb 1987
OHMEDA 7400 ANESTHESIA VENTILATOR
K864129 · Ohmeda Medical · Dec 1986
EMERSON 3MV VOLUME VENTILATOR
K864379 · J. H. Emerson Co. · Dec 1986
LUNG MECHANICS SOFTWARE PROGRAM
K864105 · Siemens Elema AB · Nov 1986