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510(k) K961914

BACTERIA/VIRAL FILTER by Hudson Respiratory Care, Inc. — Product Code CAH

K961914 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "BACTERIA/VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on August 14, 1996. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
May 17, 1996
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 Hudson Respiratory Care, Inc.

  • K031383 — MODEL 780 (July 7, 2003)
  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K010402 — SMOOTH-FLO CIRCUIT (March 14, 2001)
  • K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, (November 3, 2000)
  • K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-4 (May 24, 2000)
  • K994352 — SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 (March 22, 2000)
  • K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (February 21, 1997)
  • K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA (September 10, 1996)
  • K955645 — CATH-GUIDE (March 12, 1996)

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