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510(k) K020629

SIMPLICITY SIMPLEX SOFT INFUSION SET by Sterling Medivations, Inc. — Product Code FPA

K020629 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY SIMPLEX SOFT INFUSION SET". The FDA issued a decision of Substantially Equivalent on Apr 1, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 1, 2002
Date Received
Feb 26, 2002
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
510(k)

Other clearances by Sterling Medivations, Inc.

  • K021530 — SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO… (May 21, 2002)
  • K021487 — SIMPLICITY EASY ACCESS P INFUSION SET (May 17, 2002)
  • K021296 — SIMPLICITY QD EASY P INFUSION SET (May 14, 2002)
  • K021216 — SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION… (May 3, 2002)
  • K021005 — SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS… (Apr 25, 2002)
  • K020912 — SIMPLICITY EASY SOFT INFUSION SET (Apr 10, 2002)
  • K020990 — SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO… (Apr 10, 2002)
  • K014061 — SIMPLICITY STARPLUS SOFT INFUSION SET (Jan 17, 2002)
  • K014062 — SIMPLICITY EASY ACCESS INFUSION SET (Jan 17, 2002)
  • K013767 — SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN… (Dec 12, 2001)

Other clearances for product code FPA

  • K260261 — Gravity Blood Sets with 200µm Filter (Oct 22, 2026)
  • K254123 — Ecomed Disposable Administration Sets (Sep 11, 2026)
  • K261530 — iiSure Infusion Set (Jun 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) (Feb 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle… (Dec 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (Oct 30, 2025)
  • K251814 — EZ™ IV Administration Set (Aug 29, 2025)
  • K251854 — SteadiSet infusion set (Aug 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (Aug 1, 2025)

FDA data resources

Source: FDA 510(k) database entry for K020629. Report a data issue: hello@regdatalab.com.