Cleared Traditional

K791468 - RESUSCI-BAG-VALVE

K791468 is an FDA 510(k) clearance for RESUSCI-BAG-VALVE, manufactured by Concept, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K791468 · Concept, Inc. · Anesthesiology device
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Aug 1979
Decision
16d
Days
Class 2
Risk

K791468 is an FDA 510(k) clearance for the RESUSCI-BAG-VALVE. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1979 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Concept, Inc. devices

FDA 510(k) Submission Details - K791468

510(k) Number K791468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date August 22, 1979
Days to Decision 16 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
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 75
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K791468.
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · Siemens Elema AB · Oct 1982
RESUSCITATION CIRCUIT
K812273 · Vital Signs, Inc. · Aug 1981
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813 · Puritan Bennett Corp. · Dec 1980
LIFESAVER, MANUAL #5160
K780216 · Hudson Oxygen Therapy Sales Co. · Mar 1978
AMBU RESUSCITATOR
K771350 · Air-Shields, Inc. · Aug 1977