Cleared Traditional

K792456 - PNEUPAC VENTILATOR/RESUSCITATOR #3

K792456 is an FDA 510(k) clearance for PNEUPAC VENTILATOR/RESUSCITATOR #3, manufactured by Pneupac , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K792456 · Pneupac , Ltd. · Anesthesiology device
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Feb 1980
Decision
64d
Days
Class 2
Risk

K792456 is an FDA 510(k) clearance for the PNEUPAC VENTILATOR/RESUSCITATOR #3. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Pneupac , Ltd. (Walker, US). The FDA issued a Cleared decision on February 5, 1980 after a review of 64 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 Pneupac , Ltd. devices

FDA 510(k) Submission Details - K792456

510(k) Number K792456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date February 05, 1980
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
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 319
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K792456.
CAM-10 EXSUFFLATION BELT #11-001
K800999 · Lifecare Services, Inc. · May 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · Hospal Medical Corp. · Apr 1980
SIEMENS-ELEMA AB MANUAL VENTILATION
K800114 · Siemens Elema AB · Mar 1980
VICKERS MEDICAL MODEL 130 NEAVENT-NEO
K791713 · Vickers America Medical Corp. · Sep 1979
CAM-10 BATTERY PACK (#7-001)
K791188 · Lifecare Services, Inc. · Jul 1979
RESPIRAOTR, CAM-10 RBL
K790605 · Lifecare Services, Inc. · Jul 1979