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510(k) K011580

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

K011580 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY SOFT QD SILVER INFUSION SET". The FDA issued a decision of Substantially Equivalent on Jun 5, 2001. 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
Jun 5, 2001
Date Received
May 22, 2001
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
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)
  • K020629 — SIMPLICITY SIMPLEX SOFT INFUSION SET (Apr 1, 2002)
  • K014061 — SIMPLICITY STARPLUS SOFT INFUSION SET (Jan 17, 2002)
  • K014062 — SIMPLICITY EASY ACCESS INFUSION SET (Jan 17, 2002)

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 K011580. Report a data issue: hello@regdatalab.com.