Cleared Traditional

K792564 - MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR

K792564 is an FDA 510(k) clearance for MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR, manufactured by Eastern Anesthesia, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K792564 · Eastern Anesthesia, Inc. · Anesthesiology device
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Dec 1979
Decision
7d
Days
Class 2
Risk

K792564 is an FDA 510(k) clearance for the MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Eastern Anesthesia, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 7 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.

FDA 510(k) Submission Details - K792564

510(k) Number K792564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1979
Decision Date December 19, 1979
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 140d · This submission: 7d
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 455
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K792564.
PNEUPAC VENTILATOR/RESUSCITATOR #2
K792455 · Pneupac , Ltd. · Feb 1980
PNEUPAC VENTILATOR/RESUSCITATOR #3
K792456 · Pneupac , Ltd. · Feb 1980
PNEUPAC VENTILATOR/RESUSCITATOR
K792459 · Pneupac , Ltd. · Feb 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
K792564 · MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR
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