BD FlowSmart Set/MiniMed Pro-Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181718 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 medications, including insulin, via external infusion pumps. It features a flexible perforated catheter integrated perpendicularly with an adhesive patch and detachable tubing, facilitating secure and stable subcutaneous placement.
This device is intended for single-use in hospital settings and has received FDA 510(k) clearance under the Traditional pathway as a Class 2 General Hospital device (Product Code: FPA). Supplied sterile, it requires no additional preparation beyond standard aseptic handling prior to use, adhering to standard infusion pump compatibility standards.
Frequently asked questions
What types of medications can the BD FlowSmart Set/MiniMed Pro-Set be used to administer, and is it compatible with all insulin pumps?
The BD FlowSmart Set/MiniMed Pro-Set is specifically designed for the administration of insulin and other compatible medications via external infusion pumps. It is engineered to meet standard infusion pump compatibility standards, meaning it should work with most insulin pumps on the market. However, always verify compatibility with your specific pump model before use, as individual devices may have unique requirements.
Is the BD FlowSmart Set/MiniMed Pro-Set intended for use outside of hospitals, or is it strictly for hospital settings?
The device is intended for single-use in hospital settings only, as explicitly stated in its description. While it may be compatible with external infusion pumps, its regulatory clearance and labeling restrict its use to controlled clinical environments like hospitals.
How is the BD FlowSmart Set/MiniMed Pro-Set packaged and prepared for use?
The BD FlowSmart Set/MiniMed Pro-Set is supplied sterile and requires no additional preparation beyond standard aseptic handling before use. The packaging ensures sterility, and the device is ready to attach to an infusion pump after opening, provided proper infection control protocols are followed.
What makes the BD FlowSmart Set/MiniMed Pro-Set unique in terms of its design for subcutaneous infusion?
The set features a flexible perforated catheter that integrates perpendicularly with an adhesive patch, allowing for secure and stable subcutaneous placement. The detachable tubing design enhances ease of use, reducing the risk of dislodgment while maintaining a stable infusion pathway.
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 (K160651) — 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 | K181718 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K181718 24 fields · synced Sep 18, 2026