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Altera Filter and HME/Filter

by Meditera Tibbi Malzeme San VE Tic AS

510(k) K192713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK192713 Date16 Mar 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1160-2023 FDA Class III initiated 5 Jan 2023

    Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

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  • Withdrawn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

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