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Westmed Circularie Pep Devices

by Westmed Intl.

510(k) K955047

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 NumberK955047 Date27 Mar 1996ClearedStatusActive

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  • Withdrawn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
BYE
Device Class
Class II
Regulation
21 CFR Part 868.5965
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.

This device is an attachment for breathing positive end expiratory pressure (PEEP). It is designed to provide positive end expiratory pressure during respiratory support.

It is supplied as a reusable device and is classified as a Class II medical device under FDA regulation number 868.5965. The device received traditional 510(k) clearance (K955047) on March 27, 1996, based on substantial equivalence to a predicate device, and is intended for use in anesthesiology settings.

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