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510(k) K152050

Pencylcap by B.Braun Melsungen AG — Product Code FMI

K152050 is an FDA 510(k) premarket notification submitted by B.Braun Melsungen AG for the device "Pencylcap". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. B.Braun Melsungen AG has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2016
Date Received
July 23, 2015
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 B.Braun Melsungen AG

  • K163358 — Introcan Safety 3 Closed IV Catheter (April 28, 2017)
  • K131040 — EXTAVIPRO STERICAN 30G (July 15, 2013)
  • K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (3 (August 30, 2011)
  • K102033 — COMBITRANS MONITORING SETS AND ACCESSORIES (April 7, 2011)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (September 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (August 25, 2026)
  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • 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)

FDA data resources