Cleared Traditional

K964979 - POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER

K964979 is an FDA 510(k) clearance for POROUS MEDIA DBF23 DISPOSABLE RESPIRATO..., manufactured by Porous Media Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K964979 · Porous Media Corp. · General Hospital
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Mar 1997
Decision
89d
Days
Class 2
Risk

K964979 is an FDA 510(k) clearance for the POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Porous Media Corp. (St. Paul, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 - K964979

510(k) Number K964979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date March 11, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 168
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K964979.
FILTER
K970102 · Promedic, Inc. · Jun 1997
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K964382 · Gibeck, Inc. · Apr 1997
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K965020 · Porous Media Corp. · Mar 1997
9000 SERIES FILTER & FILTER/HME
K963053 · Enternet Medical, Inc. · Feb 1997
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
ENGSTROM HMEF 1000
K964204 · Datex Engstrom AB · Nov 1996