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Triumph-1 Port

by Horizon Medical Products, Inc.

510(k) K951814

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK951814 Date29 Aug 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0406-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010 on shared 510(k) K951814

    Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

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  • Withdrawn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
LJT
Device Class
Class II
Regulation
21 CFR Part 880.5965
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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