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Express Chest Drain

by Atrium Medical Corporation

510(k) K081718

Express Chest Drain is a Class II device made by Atrium Medical Corporation, cleared under FDA 510(k) K081718 on 25 Jul 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081718 Date25 Jul 2008ClearedStatusActive

Official records

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1938-2015 FDA Class II initiated 7 May 2015 on shared 510(k) K081718
    • Terminated Z-1935-2015 FDA Class II initiated 7 May 2015 on shared 510(k) K081718
    • Terminated Z-1937-2015 FDA Class II initiated 7 May 2015 on shared 510(k) K081718
    • Terminated Z-1936-2015 FDA Class II initiated 7 May 2015 on shared 510(k) K081718

    Chest drains have a missing o-ring

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K081718
  2. Recall initiated FDA recalls Z-1938-2015
  3. Recall initiated FDA recalls Z-1935-2015
  4. Recall initiated FDA recalls Z-1937-2015
  5. Recall initiated FDA recalls Z-1936-2015

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  • Withdrawn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
KDQ
FDA applicant
Atrium Medical Corp.
Device class
Class II
Regulation
21 CFR Part 880.6740
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KDQ (Bottle, Collection, Vacuum).

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