Simplicity Easy Access II Infusion Set

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

Full name

Simplicity Easy Access II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface

510(k) Number

K021005 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

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. →

• What types of fluids can the Simplicity Easy Access II Infusion Set deliver, and how is it typically used in clinical settings?

  The Simplicity Easy Access II Infusion Set is designed for the controlled infusion or injection of fluids such as medications, nutrients, or other solutions directly into subcutaneous tissue—below the skin surface. It is intended for use with external pumps or syringes to provide continuous or intermittent administration, making it suitable for applications like chemotherapy, hydration therapy, or nutritional support.

• Is the Simplicity Easy Access II Infusion Set reusable, and if not, how should it be handled to maintain sterility before use?

  The device is explicitly labeled as single-use and supplied pre-sterilized in a ready-to-use format. To preserve sterility, it must be stored in a clean, dry environment until use, following standard aseptic handling protocols for subcutaneous infusion applications. Opening or handling the packaging should be done in a sterile field to prevent contamination.

• What regulatory pathway does the Simplicity Easy Access II Infusion Set follow, and how does this affect its use in hospitals?

  The device is regulated under FDA 510(k) clearance (K021005) and is classified as substantially equivalent to prior-generation infusion sets. This means it has undergone review by the FDA’s General Hospital Orthopaedic (HO) Advisory Committee and is approved for use in clinical settings where percutaneous infusion is indicated, such as hospitals or outpatient care facilities.

• Can the Simplicity Easy Access II Infusion Set be used in MRI environments, and what storage conditions are recommended?

  The device is explicitly not MRI-compatible, so it should not be used in magnetic resonance imaging environments. For storage, it must be kept in a clean, dry location until use, adhering to standard protocols for subcutaneous infusion devices to ensure safety and sterility.