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510(k) K092129

INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 by Intersurgical, Inc. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2010
Date Received
July 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
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)
  • 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)
  • K983610 — CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MIN (April 30, 1999)

Other clearances for product code BZE

  • K243244 — Heated Breathing Tube (July 25, 2025)
  • K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (August 2, 2024)
  • K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD9903 (June 4, 2024)
  • K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (M (June 14, 2023)
  • K201418 — Sunset Heated CPAP Tube (January 29, 2021)
  • K173280 — Neonatal ConchaSmart Breathing Circuits (August 2, 2018)
  • K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit (September 14, 2017)
  • K153234 — AirLife Adult Heated Wire Circuit (July 7, 2016)
  • K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (June 23, 2016)
  • K151461 — Hybernite RT (March 24, 2016)