Cleared Traditional

K965020 - POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER

K965020 is an FDA 510(k) clearance for POROUS MEDIA DBF23 REUSABLE RESPIRATORY..., 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 88-day FDA review.

K965020 · Porous Media Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
88d
Days
Class 2
Risk

K965020 is an FDA 510(k) clearance for the POROUS MEDIA DBF23 REUSABLE 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 14, 1997 after a review of 88 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 - K965020

510(k) Number K965020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date March 14, 1997
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K965020.
SPIROSAFE FILTER
K973314 · Micro Direct, Inc. · Nov 1997
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 DISPOSABLE RESPIRATORY FILTER
K964979 · 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