Cleared Traditional

K800125 - VENTILATOR TEST LUNG

K800125 is an FDA 510(k) clearance for VENTILATOR TEST LUNG, manufactured by Bio-Med Devices, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K800125 · Bio-Med Devices, Inc. · Anesthesiology device
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Jan 1980
Decision
6d
Days
Class 2
Risk

K800125 is an FDA 510(k) clearance for the VENTILATOR TEST LUNG. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1980 after a review of 6 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 Bio-Med Devices, Inc. devices

FDA 510(k) Submission Details - K800125

510(k) Number K800125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date January 24, 1980
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 140d · This submission: 6d
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 423
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K800125.
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