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Adult Evaqua 2 Dual Heated Breathing Circuits

by Fisher & Paykel Healthcare, Inc.

510(k) K122432

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122432 Date6 Dec 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZE
FDA applicant
Fisher & Paykel Healthcare, Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5270
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Adult Evaqua 2 Dual Heated Breathing Circuits are heater breathing systems with or without controllers, not humidifiers or nebulizers, designed for adult patients. These circuits utilize Evaqua technology that allows water vapor to diffuse through the expiratory limb wall to minimize condensation within the circuit or ventilator.

The circuits are intended for single-patient use and are supplied in various sizes. They are authorized under FDA 510K clearance with product code BZE and are regulated under 868.5270. The device is classified as Class II and is intended for use in anesthesiology settings.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Adult Evaqua 2 Dual Heated Breathing Circuits?

    These circuits are heater breathing systems designed for adult patients in anesthesiology settings. They utilize Evaqua technology that allows water vapor to diffuse through the expiratory limb wall to minimize condensation within the circuit or ventilator.

  • Are these breathing circuits single-use or reusable?

    The Adult Evaqua 2 Dual Heated Breathing Circuits are intended for single-patient use only. They are not designed to be reused between different patients.

  • What sizes are available for the Adult Evaqua 2 Dual Heated Breathing Circuits?

    These circuits are supplied in various sizes to accommodate different patient needs, though the specific sizes available are not detailed in the provided information.

  • What is the regulatory classification of these breathing circuits?

    The device is classified as Class II and is authorized under FDA 510K clearance with product code BZE, regulated under 868.5270. It is intended for use in anesthesiology settings.