đź“‹ FDA Reference
Simplicity Easy P Soft Infusion Set for Infusion and or Injection of Fluids Into the Body Below the Surface of the Skin
Sterling Medivations
Summary: The Simplicity Easy P Soft Infusion Set is a medical device used for the infusion or injection of fluids beneath the skin. It is commonly used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021530 ↗
Decision Date ?
May 21, 2002
Product Code ?
FPA
Device Class ?
Class 2
Evidence ?
0 studies
The Simplicity Easy P Soft Infusion Set was cleared through the FDA 510(k) pathway on May 21, 2002. It is manufactured by Sterling Medivations and is classified as a Class 2 device.
What It Is
The Simplicity Easy P Soft Infusion Set is designed for the subcutaneous delivery of fluids, such as medications or nutrients. It consists of a soft, flexible cannula that is inserted under the skin, connected to tubing that allows for controlled infusion. This device is particularly useful for patients requiring regular or continuous fluid administration.
FDA-Cleared Indications
- Infusion of fluids beneath the surface of the skin
- Injection of fluids beneath the surface of the skin
Clinical Applications
- Subcutaneous delivery of medications when prescribed with an appropriate infusion system
- Subcutaneous delivery of fluids in clinical or home-care settings
- Intermittent or continuous subcutaneous infusion using compatible equipment
Practical Considerations
- Use only with compatible tubing, connectors, syringes, or infusion pumps and follow the product labeling.
- Insertion requires aseptic technique and routine monitoring for redness, pain, swelling, leakage, blockage, or infection.
- The appropriate cannula length and configuration depend on the patient, treatment, infusion fluid, and insertion site; available sizes should be confirmed with the manufacturer.
- MRI compatibility is not established by the provided FDA record. Confirm the complete set's MRI labeling before an MRI examination and follow institutional MRI-safety procedures.
- Do not use if the device is damaged, contaminated, expired, or incompatible with the prescribed fluid or delivery equipment.
Frequently Asked Questions
What is the Simplicity Easy P Soft Infusion Set used for?
It is used for the subcutaneous infusion or injection of fluids, such as medications or nutrients.
What specialties typically use this device?
Specialties such as oncology, endocrinology, and pain management commonly use this device.
What are the FDA-cleared indications?
The device is cleared for the infusion or injection of fluids beneath the skin, suitable for patients needing regular medication delivery.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.