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510(k) K983610

CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 by Intersurgical, Inc. — Product Code CAH

K983610 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18". The FDA issued a decision of Substantially Equivalent on April 30, 1999. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
October 14, 1998
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 Intersurgical, Inc.

  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K122077 — MANOMETER (January 10, 2013)
  • K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (December 20, 2012)
  • K121026 — FLO-GUARD BREATHING FILTER (November 2, 2012)
  • K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTE (October 29, 2010)
  • K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2 (May 18, 2010)
  • K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD (March 10, 2010)
  • K032322 — CLEAR-THERM MICRO HME, MODEL 1441 (May 13, 2004)
  • K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH (June 24, 2003)
  • K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W (June 15, 1999)

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