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510(k) K241353

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set by Bard Access Systems, Inc. — Product Code PTI

K241353 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2024
Date Received
May 13, 2024
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 Bard Access Systems, Inc.

  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • K240146 — BD Prevue™ II Peripheral Vascular Access System (February 18, 2024)
  • K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (November 10, 2022)
  • K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (August 24, 2022)
  • K210264 — BD PowerPiCC Catheter (July 30, 2021)
  • K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (May 30, 2012)
  • K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)
  • K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 18, 2007)

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)
  • 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)
  • K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (August 8, 2017)

FDA data resources