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510(k) K251854

SteadiSet infusion set by Tandem Diabetes Care — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2025
Date Received
June 17, 2025
Clearance Type
Abbreviated
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

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Other clearances for product code FPA

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  • 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)
  • K243529 — Solution Administration Sets (March 14, 2025)