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510(k) K853527

JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET by Jufrey Multimed Corp. — Product Code FPA

K853527 is an FDA 510(k) premarket notification submitted by Jufrey Multimed Corp. for the device "JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET". The FDA issued a decision of Substantially Equivalent on September 23, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jufrey Multimed Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1985
Date Received
August 8, 1985
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 Jufrey Multimed Corp.

  • K861519 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F) (May 27, 1986)
  • K861518 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F) (May 27, 1986)
  • K861523 — STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) (May 27, 1986)
  • K861521 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330) (May 27, 1986)
  • K861520 — UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205) (May 27, 1986)
  • K853327 — JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION (August 21, 1985)

Other clearances for product code FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • 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)

FDA data resources