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510(k) K925927

MPC-1000 INJECTION CAP/PLUG by Molded Products, Inc. — Product Code FPA

K925927 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "MPC-1000 INJECTION CAP/PLUG". The FDA issued a decision of Substantially Equivalent on August 16, 1993. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Molded Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1993
Date Received
November 23, 1992
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 Molded Products, Inc.

  • K022068 — TUBING, DIALYSATE (AND CONNECTOR) (September 23, 2002)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K010712 — DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (September 27, 2001)
  • K003712 — MODIFICATION TO MALE TO MALE LUER ADAPTER (May 16, 2001)
  • K925978 — MPC-80 TRANSDUCER (January 14, 1994)
  • K925930 — MPC-150 MALE TO MALE LUER ADAPTER (August 16, 1993)

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