Cleared Traditional

K840345 - IMPULSE VENTILATOR

K840345 is an FDA 510(k) clearance for IMPULSE VENTILATOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K840345 · Healthdyne, Inc. · Anesthesiology device
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Feb 1984
Decision
28d
Days
Class 2
Risk

K840345 is an FDA 510(k) clearance for the IMPULSE VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1984 after a review of 28 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K840345

510(k) Number K840345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date February 23, 1984
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K840345.
INFANT STAR VENTILATOR
K840865 · Infrasonics Corp. · Apr 1984
CONTINUOUS VENTILATOR
K840119 · Bear Medical Systems, Inc. · Apr 1984
MODEL IV 100B-DA INFANT VENTILATOR
K833982 · Sechrist Industries, Inc. · Mar 1984
VOLUME VENTILATOR
K832508 · Sechrist Industries, Inc. · Dec 1983
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983
PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · Pneupac , Ltd. · Nov 1983