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510(k) K163591

BD PosiFlush Heparin Lock Flush Syringe by Becton, Dickinson and Company — Product Code NZW

K163591 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD PosiFlush Heparin Lock Flush Syringe". The FDA issued a decision of Substantially Equivalent on February 27, 2017. The device falls under product code NZW (Heparin, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2017
Date Received
December 20, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heparin, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

Other clearances by Becton, Dickinson and Company

  • K260128 — BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (April 15, 2026)
  • K252506 — BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Bloo (April 10, 2026)
  • K252378 — BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillar (April 10, 2026)
  • K260184 — Onclarity™ Self-Collection Kit (April 2, 2026)
  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)

Other clearances for product code NZW

  • K133446 — HEPARIN LOCK / FLUSH SYRINGES (November 14, 2014)
  • K092938 — HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, (June 18, 2010)
  • K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN (February 3, 2010)
  • K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE (June 10, 2009)
  • K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (February 23, 2007)
  • K023740 — SYREX PRE-FILLED SYRINGE (May 13, 2003)

FDA data resources