Skip to content

Circuit Guard

by Arc Medical Inc.

510(k) K982239

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 NumberK982239 Date14 Aug 1998ClearedStatusActive

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  • Withdrawn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
FDA applicant
Arc Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 868.5260
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Circuit Guard is a bacterial filter for breathing circuits, classified as a Class 2 medical device under product code CAH. It is designed to protect anesthesia circuits and equipment, including ETCO2 monitoring components, from contamination and to safeguard patients from exposure to contaminated circuits and equipment.

The device is supplied as a sterile, single-use filter intended for use in general hospital settings, particularly within anesthesiology. It received FDA 510(k) clearance (K982239) through the traditional pathway on August 14, 1998, and is manufactured by Arc Medical, Inc. No information regarding MRI safety, storage conditions, or specific sizes is provided in the data.

Other devices from Arc Medical Inc.

Questions

AI-generated answers, 1 Oct 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 Circuit Guard used for?

    The Circuit Guard is a bacterial filter designed to protect anesthesia breathing circuits and equipment, including ETCO2 monitoring components, from contamination. It also safeguards patients from exposure to contaminated circuits and equipment during use in general hospital settings, particularly within anesthesiology.

  • Is the Circuit Guard sterile and single-use or reusable?

    The Circuit Guard is supplied as a sterile, single-use filter. It is intended for one-time use only and should not be reprocessed or reused, as this could compromise its integrity and increase the risk of contamination or infection.

  • What regulatory pathway was used for the Circuit Guard's FDA clearance?

    The Circuit Guard received FDA 510(k) clearance through the traditional pathway. Its clearance number is K982239, and the decision was made on August 14, 1998, based on a determination of substantial equivalence to a legally marketed predicate device.