Home / 510(k) Clearances / K122432

510(k) K122432

ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS by Fisher &Paykel Healthcare , Ltd. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2012
Date Received
August 10, 2012
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 Fisher &Paykel Healthcare , Ltd.

  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTI (November 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243917 — F&P Optiflow Air/Oxygen Flow Source (July 14, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K233643 — F&P Airvo 3 NIV (PT311US) (August 9, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)
  • K231956 — F&P Optiflow+ Duet Nasal Cannula (February 7, 2024)

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)