📋 FDA Reference
Unifine Pentips Unifine Pentips Plus
Owen Mumford
Summary: Unifine Pentips are pen needles used for subcutaneous injections, commonly utilized by patients with diabetes for insulin administration. They are designed for ease of use and comfort.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152339 ↗
Decision Date ?
June 24, 2016
Product Code ?
FMI
Device Class ?
Class 2
Evidence ?
0 studies
The Unifine Pentips by Owen Mumford were cleared through the FDA 510k pathway on June 24, 2016. It is a Class 2 medical device under product code FMI.
What It Is
Unifine Pentips are pen needles designed for delivering subcutaneous injections, primarily insulin. They feature a thin, sharp needle to minimize discomfort during injection. The device is compatible with most insulin pens, offering a convenient and effective solution for patients requiring regular insulin administration.
FDA-Cleared Indications
- For single-use subcutaneous injections when attached to a compatible medication pen.
- For use with compatible pen-injector devices to administer medication through the skin.
- Intended for patients who require medication delivered by subcutaneous injection, including insulin therapy.
Clinical Applications
- Subcutaneous insulin injections for people with diabetes using compatible insulin pens.
- Routine self-administration of medication supplied in a compatible pen-injector device.
- Subcutaneous medication administration in outpatient or clinical settings.
- Use by adults or children when the needle size and pen device are appropriate for the patient and medication.
Practical Considerations
- Available in multiple needle lengths and gauges; selection should follow the medication instructions and clinician guidance.
- Compatibility with the specific medication pen should be confirmed before use.
- These needles are intended for single use and should be placed in an approved sharps container immediately after injection.
- Do not share pen needles, even when the pen device is changed or the needle appears unused.
- The needle is not an implant and has no expected long-term duration; a new needle is used for each injection.
Related Literature
The linked study compared the user performance and experience of the Nucleus Pen with commercially available pen needles. Although specific findings are not detailed, such studies typically assess ease of use, comfort, and user satisfaction. Limitations may include a small sample size or lack of diverse patient demographics.
Frequently Asked Questions
What is Unifine Pentips used for?
Unifine Pentips are used for administering subcutaneous injections, primarily insulin, in patients with diabetes.
What specialties typically use this device?
Endocrinologists and primary care physicians commonly use this device for managing diabetes.
What are the FDA-cleared indications?
Unifine Pentips are indicated for use in patients requiring subcutaneous injections, such as those with diabetes needing insulin therapy.
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.