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510(k) K982127

POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER by Porous Media Corp. — Product Code CAH

K982127 is an FDA 510(k) premarket notification submitted by Porous Media Corp. for the device "POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER". The FDA issued a decision of Substantially Equivalent on June 23, 1998. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Porous Media Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1998
Date Received
June 17, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Porous Media Corp.

  • K062091 — POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (August 8, 2006)
  • K061426 — OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 (June 5, 2006)
  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K965020 — POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER (March 14, 1997)
  • K964979 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (March 11, 1997)
  • K952428 — POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER (July 7, 1995)
  • K934132 — POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (October 4, 1994)

Other clearances for product code CAH

  • K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (May 15, 2026)
  • K251583 — Ambu® Virobac II® Exhalation Filter (April 30, 2026)
  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K222917 — Breathing circuit bacterial/viral filter (February 15, 2024)
  • K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (September 16, 2023)
  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)

FDA data resources