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Cpi, Maxi-Vac(6480), Thomas Industries, Medi-Pump(1240/1242/1243)

by Thomas Industries

510(k) K965059

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK965059 Date4 Mar 1997ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2150-2015 FDA Class II initiated 4 Jun 2015 on shared 510(k) K965059
    • Terminated Z-2149-2015 FDA Class II initiated 4 Jun 2015 on shared 510(k) K965059
    • Terminated Z-2151-2015 FDA Class II initiated 4 Jun 2015 on shared 510(k) K965059

    Vacuum pump may not perform to specification.

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

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  • Withdrawn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
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Thomas Industries

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