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510(k) K020530

EVANS SUB-Q, MODEL MC4206 by Evans Medical, Inc. — Product Code FPA

K020530 is an FDA 510(k) premarket notification submitted by Evans Medical, Inc. for the device "EVANS SUB-Q, MODEL MC4206". The FDA issued a decision of Substantially Equivalent on April 29, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Evans Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2002
Date Received
February 19, 2002
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 Evans Medical, Inc.

  • K935480 — MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS (January 28, 1994)
  • K935641 — 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS (January 28, 1994)
  • K935642 — EVANS MEDICAL EXTENSION SETS (January 28, 1994)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources