BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin S…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170386 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Ultra-Fine and BD Ultra-Fine II Insulin Syringes are insulin delivery devices designed for subcutaneous administration of insulin. These syringes feature ultra-fine 31-gauge needles, optimized for reduced injection discomfort and improved patient compliance. The BD Insulin Syringes with BD Ultra-Fine or Micro-Fine IV Needles are engineered for precise dosing, ensuring accurate insulin delivery in diabetes management.
These syringes are supplied in single-use, sterile packaging and are intended for use in clinical and home healthcare settings. Available in various capacities (0.3mL, 0.5mL, and 1mL) and needle lengths (6mm, 8mm, and 12.7mm), they are compatible with most diabetes pens and insulin cartridges. The devices are classified under FDA 510(k) clearance (K170386) as substantially equivalent to the predicate device, adhering to regulatory standards for insulin delivery systems.
Frequently asked questions
What needle gauge and lengths are available for these insulin syringes, and why does this matter for patients?
The BD Ultra-Fine and BD Ultra-Fine II syringes feature 31-gauge needles, which are thinner than standard insulin needles, reducing injection discomfort and improving patient compliance. Needle lengths available are 6mm, 8mm, and 12.7mm, allowing for flexibility based on patient body type and subcutaneous fat depth. The shorter lengths (6mm–8mm) are often preferred for thinner patients or children, while the 12.7mm option accommodates deeper tissue layers. This design minimizes pain and bruising, making self-administration more tolerable.
Are these syringes meant for single-use only, and if so, how should they be stored to maintain sterility?
Yes, these syringes are single-use only and supplied in sterile packaging to ensure patient safety. To maintain sterility, store them in a cool, dry place (not refrigerated) away from direct sunlight or extreme temperatures. Unopened syringes should be kept in their original packaging until use, and any unused syringes should be discarded immediately after administration to prevent contamination or infection.
What syringe sizes (capacities) are offered, and how do they differ in practical use for diabetes management?
The syringes come in 0.3mL, 0.5mL, and 1mL capacities, catering to different insulin dosing needs. The 0.3mL size is ideal for precise dosing of short-acting or rapid-acting insulins (e.g., 10–30 units), while the 0.5mL and 1mL sizes accommodate larger doses (e.g., basal insulins or higher unit requirements). The smaller sizes reduce waste and improve accuracy for patients requiring lower doses, whereas the larger sizes offer convenience for those needing higher volumes.
Can these syringes be used with insulin pens or cartridges, and what compatibility considerations should clinicians or patients keep in mind?
Yes, these syringes are compatible with most diabetes pens and insulin cartridges, though compatibility depends on the pen’s design and the syringe’s connector type. The BD Ultra-Fine needles are engineered to work seamlessly with standard insulin cartridges and pens, minimizing dead-space volume for accurate dosing. Patients should verify their specific pen model’s compatibility with the syringe’s hub or adapter, as some pens require proprietary connectors. Always follow the manufacturer’s instructions to avoid leaks or dosing errors.
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: Amazon.com: BD Ultra-Fine, Amazon.com: BD Ultra-Fine Insulin Syringes 31G 1cc 5/16" 90/bx, BD Ultra-Fine™ Insulin Syringes - embecta.com, BD (company) - Wikipedia, BD Ultra-Fine™ Insulin syringes - embecta.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170386 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- FDA Applicant
- Becton Dickinson & Company
Sources (1)
- FDA 510(k) K170386 24 fields · synced Oct 6, 2026