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510(k) K032150

SAFETY-MULTIFLY by Sarstedt, Inc. — Product Code FPA

K032150 is an FDA 510(k) premarket notification submitted by Sarstedt, Inc. for the device "SAFETY-MULTIFLY". The FDA issued a decision of Substantially Equivalent on September 12, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sarstedt, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2003
Date Received
July 14, 2003
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 Sarstedt, Inc.

  • K051019 — SAFETY NEEDLE (July 25, 2005)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K024237 — URINE MONOVETTE BORIC ACID (April 14, 2003)
  • K003382 — SARSTEDT NEEDLE PROTECTOR (March 30, 2001)
  • K913622 — HEMOPLUS (January 31, 1992)

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