BD FlowSmart Set MiniMed Pro-Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160651 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD FlowSmart Set MiniMed Pro-Set is a subcutaneous infusion set designed for the administration of fluids, including insulin, from an external infusion pump. It features a flexible, perforated catheter positioned perpendicular to an adhesive patch, connected via detachable tubing to facilitate secure and stable placement under the skin.
This device is intended for single-use and is supplied sterile for clinical use in hospital settings. It is classified as a Class 2 General Hospital device under product code FPA and has received FDA 510(k) clearance through the Special 510(k) pathway. The set is intended to interface with commercially available infusion pumps with compatible connections.
Frequently asked questions
What types of fluids can the BD FlowSmart Set, MiniMed Pro-Set be used to administer, and is it compatible with specific infusion pumps?
The BD FlowSmart Set, MiniMed Pro-Set is specifically designed for subcutaneous infusion of fluids, including insulin, from an external infusion pump. It is engineered to interface with commercially available infusion pumps that have compatible connection types, ensuring secure and stable delivery of the intended medication.
Is the BD FlowSmart Set, MiniMed Pro-Set intended for reuse, or is it meant to be used only once?
The BD FlowSmart Set, MiniMed Pro-Set is explicitly intended for single-use only. This design ensures patient safety and sterility, as it is supplied sterile for clinical use in hospital settings, preventing cross-contamination or degradation of performance with repeated use.
How is the BD FlowSmart Set, MiniMed Pro-Set secured under the skin, and what makes its placement stable?
The set features a flexible, perforated catheter positioned perpendicular to an adhesive patch, which helps anchor it securely under the skin. The catheter is connected via detachable tubing, allowing for stable placement and minimizing movement once inserted, which is critical for consistent fluid administration.
Where is this device primarily used, and what kind of environment is it intended for?
The BD FlowSmart Set, MiniMed Pro-Set is sterile and supplied for clinical use in hospital settings, making it suitable for controlled environments where precise subcutaneous infusion—such as insulin delivery—is required. Its design aligns with Class 2 General Hospital device standards, ensuring compliance with medical-grade safety and reliability.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its approval status?
The device received FDA 510(k) clearance through the Special 510(k) pathway, specifically under product code FPA (General Hospital). This pathway confirms that the BD FlowSmart Set, MiniMed Pro-Set is deemed substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness without requiring a full pre-market approval process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD FlowSmart Set, MiniMed Pro-Set by BECTON, DICKINSON AND COMPANY ..., K181718 FDA 510 (k) - BD FlowSmart Set/MiniMed Pro-Set, BD FlowSmart Set, MiniMed Pro-Set (K153257) — FDA 510(k) | Innolitics, BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160651 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K160651 24 fields · synced Oct 6, 2026