Home / 510(k) Clearances / K965208

510(k) K965208

POLYFIN EXTENSION SET, MODELS 126 AND 128 by Medtronic Minimed — Product Code FPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1997
Date Received
December 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Medtronic Minimed

  • K253743 — MiniMed Flex pump (March 12, 2026)
  • K253701 — SmartGuard Technology; Predictive Low Glucose Technology (February 3, 2026)
  • K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (January 15, 2026)
  • K253585 — SmartGuard technology; Predictive Low Glucose technology (January 14, 2026)
  • K253512 — MiniMed Go App (January 8, 2026)
  • K251217 — SmartGuard technology; Predictive Low Glucose technology (August 29, 2025)
  • K251032 — MiniMed 780G insulin pump (July 1, 2025)
  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K210714 — Extended Reservoir (April 6, 2022)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063114 — DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (February 9, 2007)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)