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510(k) K254095

25G Huber Needle by Martech Medical Products — Product Code PTI

K254095 is an FDA 510(k) premarket notification submitted by Martech Medical Products for the device "25G Huber Needle". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Martech Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Coring (Huber) Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Other clearances by Martech Medical Products

  • K130855 — PTFE SUPER SHEATH INTRODUCER (July 29, 2013)
  • K120617 — PTFE SUPER SHEATH INTRODUCER (November 19, 2012)
  • K101399 — COAXIAL INTRODUCER SET (June 17, 2010)
  • K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE (May 1, 1996)
  • K931924 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (August 3, 1993)
  • K922438 — PRO2 OXYGEN ANALYZER (March 5, 1993)
  • K926007 — ACCESSORY TO PISTON SYRINGE (February 23, 1993)
  • K914778 — NEOLINE(TM) (September 16, 1992)
  • K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (October 15, 1991)
  • K890473 — NEEDLE GUARD(TM) (April 3, 1989)

Other clearances for product code PTI

  • K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (November 26, 2025)
  • K251138 — Promisemed Safety Huber Needles (May 13, 2025)
  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)
  • K213823 — Intera Refill Kit (March 16, 2022)
  • K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu (October 14, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
  • K170881 — ISP Safety Huber Needle Infusion Set (December 14, 2017)
  • K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit (November 3, 2017)

FDA data resources