Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K013767 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Simplicity Wing Infusion Set

  Class II

  FDA 510(k) K010886 Active Cleared 30 Apr 2001

• Injectrite-C15 and Injectrite-C30

  Class II

  FDA 510(k) K002127 Active Cleared 29 Dec 2000

• Simplicity Easy Access P Infusion Set

  Class II

  FDA 510(k) K021487 Active Cleared 17 May 2002

• Simplicity Easy Access Infusion Set

  Class II

  FDA 510(k) K014062 Active Cleared 17 Jan 2002

• Simplicity Soft Qd Micro Infusion Set

  Class II

  FDA 510(k) K012845 Active Cleared 14 Sep 2001

• Simplicity Infuser Infusion Set

  Class II

  FDA 510(k) K010647 Active Cleared 13 Apr 2001

See all devices from Sterling Medivations, Inc. →