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510(k) K220288

NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector by Np Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2023
Date Received
February 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Np Medical, Inc.

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  • K203265 — nPro Surgical Mask (February 9, 2021)
  • K130023 — K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR (April 3, 2013)
  • K973916 — NP MEDICAL CAPLESS LUER ACTIVATED VALVE (March 9, 1998)

Other clearances for product code FPA

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  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)