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Westmed Condesate Collection Trap

by Westmed Intl.

510(k) K954271

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 NumberK954271 Date28 Dec 1995ClearedStatusActive

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  • Withdrawn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
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Westmed Condensate Collection Trap is a medical device designed to collect moisture or condensate from breathing circuits. It functions within the field of anesthesiology to manage fluid accumulation during respiratory support.

This device is regulated under FDA 510(k) clearance K954271 and is classified as a class 2 device. It is intended for use in clinical settings as specified by its regulatory authorization.

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Questions

AI-generated answers, 23 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 primary purpose of the Westmed Condensate Collection Trap?

    This device is designed to collect moisture or condensate from breathing circuits. It is used within clinical anesthesiology settings to effectively manage fluid accumulation during respiratory support.

  • What is the regulatory classification of this device?

    The Westmed Condensate Collection Trap is classified as a class 2 medical device. It has received FDA 510(k) clearance under the number K954271.

  • Which medical specialty uses this collection trap?

    This device is utilized within the field of anesthesiology. It is specifically designed to support respiratory care procedures where fluid management in breathing circuits is required.