Bent Winged Mini-Vol Infusion Set
by Med Fusion Systems, Inc. 510(k)
Active
510(k) K842143
Overview
The Bent Winged Mini-Vol Infusion Set is a subcutaneous infusion device designed for the administration of insulin from an external infusion pump. It is classified as a mini-volume infusion set, featuring a bent winged design to facilitate secure attachment to the patient’s skin. This device is intended for continuous, controlled delivery of insulin via a flexible catheter and connector system, ensuring precise dosing for diabetic management. The compact size and mini-volume capacity optimize usability for outpatient and home-based therapy.
This infusion set is supplied as a single-use, sterile medical device and is intended for subcutaneous use only, not intravenous or blood product administration. It is regulated under FDA 510(k) clearance (K842143) and falls under the General Hospital advisory committee classification. The device is designed for compatibility with insulin pumps and requires proper insertion and maintenance to avoid complications such as inaccurate dosing, infection, or site irritation. Storage and handling must adhere to sterile medical device protocols to ensure patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842143 | Date20 Jul 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Med Fusion Systems, Inc.
Questions
What is the Bent Winged Mini-Vol Infusion Set used for?
This device is specifically designed for subcutaneous insulin delivery from an external infusion pump. Its mini-volume capacity and bent winged design allow for stable attachment to the skin, enabling continuous and controlled insulin administration. This is ideal for patients requiring outpatient or home-based diabetic management, ensuring accurate dosing and ease of use.
How is the Bent Winged Mini-Vol Infusion Set supplied and what are its sterility and usage guidelines?
The infusion set is supplied as a single-use, sterile medical device. It must remain unopened until immediate use to maintain sterility. Once opened, it is intended for one-time subcutaneous use only and should not be reused or used for intravenous administration or blood products. Proper sterile handling and insertion techniques are critical to prevent complications like infection or dosing inaccuracies.
Is this infusion set compatible with all insulin pumps?
While the Bent Winged Mini-Vol Infusion Set is designed for compatibility with external insulin pumps, compatibility depends on the specific pump model and its connector system. Always verify compatibility with your pump manufacturer’s guidelines before use. The flexible catheter and connector system are optimized for secure attachment, but improper pairing could lead to leaks or dislodgement.
What storage and handling precautions should be followed?
The device must be stored in its original, unopened packaging to preserve sterility. Keep it in a clean, dry place away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants. If the packaging is damaged or compromised, do not use the set—discard it and open a new, intact unit. Proper storage ensures the integrity of the sterile barrier and reduces the risk of infection or device failure.
Why is the bent winged design important for this infusion set?
The bent winged design enhances stability by providing a wider surface area for secure attachment to the patient’s skin. This reduces the risk of accidental dislodgement during movement, which is particularly beneficial for outpatient or home use where patients may be active. The compact size of the mini-volume infusion set further optimizes usability without compromising functionality.