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Disetronic H-Tron Plus V 100 Insulin Infusion Pump

by Disetronic Medical Systems

510(k) K973044

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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)ST Traditional NumberK973044 Date15 Sep 1997DecidedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1222-04 FDA Unclassified (pre-2012) initiated 17 May 2004
    • Terminated Z-1226-04 FDA Unclassified (pre-2012) initiated 17 May 2004
    • Terminated Z-1225-04 FDA Unclassified (pre-2012) initiated 17 May 2004
    • Terminated Z-1224-04 FDA Unclassified (pre-2012) initiated 17 May 2004
    • Terminated Z-1223-04 FDA Unclassified (pre-2012) initiated 17 May 2004

    Lack of assurance of sterility.

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  • Withdrawn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
LZG
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
ST

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