Home / 510(k) Clearances / K143437

510(k) K143437

Droplet Pen Needles by Htl-Strefa S.A — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2015
Date Received
December 1, 2014
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 Htl-Strefa S.A

  • K250016 — droplet® personal lancets (July 1, 2025)
  • K220643 — DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe (July 8, 2022)
  • K202340 — Droplet Pen Needle 30G & 33G (October 15, 2020)
  • K192082 — Droplet Pen Needle 34G (April 21, 2020)
  • K171982 — DROPLET PEN NEEDLE (March 21, 2018)
  • K170988 — DropSafe Safety Pen Needle (December 12, 2017)

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)