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Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear Breathing Filter

by Intersurgical, Inc.

510(k) K092409

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 NumberK092409 Date10 Mar 2010ClearedStatusActive

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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Hydro-Guard Mini and Air-Guard Clear are breathing circuit filters and heat and moisture exchangers. These devices are designed to reduce bacterial and viral transmission to protect respiratory equipment and oxygen concentrator machines.

These devices are supplied by Intersurgical, Inc. and are authorized under FDA 510(k) number K092409. They are available in sterile options and are intended for use in anesthesia, intensive care, and home care settings.

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See all devices from Intersurgical, Inc. →

Questions

AI-generated answers, 21 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 are the Hydro-Guard Mini and Air-Guard Clear devices used for?

    These devices function as breathing circuit filters and heat and moisture exchangers. They are designed to protect respiratory equipment and oxygen concentrator machines by reducing the transmission of bacteria and viruses.

  • In which clinical settings can these filters be used?

    The filters are intended for use across a variety of environments, including anesthesia, intensive care, and home care settings, to support respiratory equipment maintenance and patient safety.

  • Are these breathing filters available in sterile options?

    Yes, these devices are available in sterile options to meet specific clinical requirements for hygiene and infection control in medical and home care environments.

  • What is the regulatory status of these Intersurgical devices?

    These devices are authorized under FDA 510(k) number K092409, which confirms they have been reviewed and found to be substantially equivalent to legally marketed predicate devices.