Cleared Traditional

K082092 - DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE

K082092 is an FDA 510(k) clearance for DISPO-BAG MANUAL RESUSCITATOR, manufactured by Galemed Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K082092 · Galemed Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
83d
Days
Class 2
Risk

K082092 is an FDA 510(k) clearance for the DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE F.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Galemed Corp. (Carlsbad, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 83 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.

FDA 510(k) Submission Details - K082092

510(k) Number K082092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date October 15, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
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 150
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K082092.
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