Cleared Special

K982127 - POROUS MEDIA DEF25 DISPOSABLE RESPIRATO...

K982127 is an FDA 510(k) clearance for POROUS MEDIA DEF25 DISPOSABLE RESPIRATO..., manufactured by Porous Media Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Special 510(k) pathway after a 6-day FDA review.

K982127 · Porous Media Corp. · General Hospital
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Jun 1998
Decision
6d
Days
Class 2
Risk

K982127 is an FDA 510(k) clearance for the POROUS MEDIA DEF25 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 June 23, 1998 after a review of 6 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Porous Media Corp. devices

FDA 510(k) Submission Details - K982127

510(k) Number K982127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date June 23, 1998
Days to Decision 6 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 129d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

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 91
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K982127.
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K974630 · Ballard Medical Products · Mar 1998
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996