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510(k) K970102

FILTER by Promedic, Inc. — Product Code CAH

K970102 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "FILTER". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
January 13, 1997
Clearance Type
Traditional
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 Promedic, Inc.

  • K131889 — EUM 100PRO (April 23, 2014)
  • K112318 — CLEARPATH 24 (June 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K031409 — URINARY CATHETERS (June 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)

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