Home / 510(k) Clearances / K874414

510(k) K874414

HYPODERMIC NEEDLES, SINGLE LUMEN by Harbor Medical Devices, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1988
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Harbor Medical Devices, Inc.

  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM (April 21, 1989)
  • K882657 — HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT (December 13, 1988)
  • K881884 — HARBOR CENTRAL VENOUS CATHETER (July 28, 1988)
  • K882190 — S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM (June 9, 1988)
  • K880297 — SEA - PORT INFUSION SET (February 19, 1988)

Other clearances for product code FMI

  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
  • K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (July 8, 2025)
  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)