Home / 510(k) Clearances / K925978

510(k) K925978

MPC-80 TRANSDUCER by Molded Products, Inc. — Product Code FIB

K925978 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "MPC-80 TRANSDUCER". The FDA issued a decision of Substantially Equivalent on January 14, 1994. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Molded Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1994
Date Received
November 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)
  • K925930 — MPC-150 MALE TO MALE LUER ADAPTER (August 16, 1993)
  • K925927 — MPC-1000 INJECTION CAP/PLUG (August 16, 1993)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (February 21, 2008)
  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (June 7, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)

FDA data resources