BioValve Insulin Delivery Systems (BIDS)
by Biovalve Technologies, Inc. 510(k)
Active
510(k) K050971
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050971 | Date16 Aug 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- LZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The BioValve Insulin Delivery Systems (BIDS) is a non-electronic, disposable insulin infusion pump classified as a Pump, Infusion, Insulin under FDA nomenclature. It is designed for the continuous delivery of insulin at set or variable rates, facilitating the management of diabetes mellitus in patients requiring insulin therapy. Unlike electronic pumps, BIDS operates without software control, relying on mechanical mechanisms for insulin infusion.
BIDS is intended for single-use and is supplied as a sterile, disposable device. It is regulated under FDA 510(k) clearance (K050971) with a product code of LZG, falling under the General Hospital advisory committee category. The system is not MRI-safe, and no additional storage or handling specifications are noted in the regulatory data. Authorisation is granted as Substantially Equivalent to predicate devices under the 880.5725 regulation.
Other devices from Biovalve Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the BioValve BIDS insulin delivery system used for?
The BioValve BIDS (Insulin Delivery Systems) is designed for the continuous delivery of insulin at set or variable rates. It is intended for patients with diabetes mellitus who require insulin therapy, providing a non-electronic alternative to traditional infusion pumps. Unlike electronic pumps, BIDS relies on mechanical mechanisms to regulate insulin flow, making it suitable for users who prefer or require a device without software control.
How is the BioValve BIDS supplied and is it reusable?
The BioValve BIDS is supplied as a sterile, disposable device, meaning each unit is intended for single-use only. This design ensures patient safety by eliminating the risk of cross-contamination or device failure associated with reuse. Disposability also simplifies handling and reduces the need for maintenance or sterilization between uses.
Is the BioValve BIDS MRI-safe?
No, the BioValve BIDS is not MRI-safe. This means patients using the device should avoid magnetic resonance imaging (MRI) procedures, as the magnetic fields could potentially interfere with the device’s mechanical components or pose safety risks. Always consult with a healthcare provider before undergoing MRI scans if using this insulin delivery system.
What regulatory approval does the BioValve BIDS hold?
The BioValve BIDS holds FDA 510(k) clearance under the classification of a Pump, Infusion, Insulin. It was determined to be Substantially Equivalent to predicate devices under the regulation number 880.5725, with a clearance number of K050971. This approval indicates that the device meets the necessary safety and performance standards for use in the United States.
Are there specific storage or handling instructions for the BioValve BIDS?
The regulatory data for the BioValve BIDS does not specify any additional storage or handling requirements beyond standard practices for sterile, single-use medical devices. It is generally recommended to store the device in a clean, dry place, protected from direct sunlight and extreme temperatures, until ready for use. Always follow manufacturer guidelines for preparation and use to ensure optimal performance and safety.