Cleared Traditional

K841818 - IMPULSE VENTILATOR

K841818 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 35-day FDA review.

K841818 · Healthdyne, Inc. · Anesthesiology device
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Jun 1984
Decision
35d
Days
Class 2
Risk

K841818 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 June 5, 1984 after a review of 35 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 - K841818

510(k) Number K841818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date June 05, 1984
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 K841818.
BEAR JET-150 VENTILATOR
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K842362 · Bear Medical Systems, Inc. · Jun 1984
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K842363 · Bear Medical Systems, Inc. · Jun 1984
BEAR 33
K841279 · Bear Medical Systems, Inc. · May 1984
SIEMENS-ELEMA VENTILATOR 900C
K841529 · Siemens Elema AB · May 1984
AB MANUAL VENTILATION ACCESS. 900C
K841393 · Siemens Elema AB · May 1984