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510(k) K110105

BD PEN NEEDLE by Becton, Dickinson and Company (BD) — Product Code FMI

K110105 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company (BD) for the device "BD PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on April 28, 2011. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Becton, Dickinson and Company (BD) has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2011
Date Received
January 13, 2011
Clearance Type
Special
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 Becton, Dickinson and Company (BD)

  • K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110) (February 25, 2026)
  • K112586 — CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (October 18, 2011)
  • K111366 — BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM (September 30, 2011)
  • K091292 — BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (August 25, 2009)

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