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510(k) K200661

Steripath Micro Blood Collection System by Magnolia Medical Technologies, Inc. — Product Code FPA

K200661 is an FDA 510(k) premarket notification submitted by Magnolia Medical Technologies, Inc. for the device "Steripath Micro Blood Collection System". The FDA issued a decision of Substantially Equivalent on October 8, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Magnolia Medical Technologies, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
March 12, 2020
Clearance Type
Special
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 Magnolia Medical Technologies, Inc.

  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K222299 — Steripath Micro Blood Collection System (November 30, 2022)
  • K192247 — Steripath Gen2 Blood Collection System (February 28, 2020)

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