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510(k) K874414

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

K874414 is an FDA 510(k) premarket notification submitted by Harbor Medical Devices, Inc. for the device "HYPODERMIC NEEDLES, SINGLE LUMEN". The FDA issued a decision of Substantially Equivalent on January 14, 1988. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Harbor Medical Devices, Inc. has at least 6 other 510(k) clearances on record.

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

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • 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)

FDA data resources