BD SoloShot Mini Syringe/ BD Auto Disable Syringe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201234 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 SoloShot Mini Syringe / BD Auto-Disable Syringe is a single-use, prefilled syringe designed for intramuscular or subcutaneous injections, classified under the nomenclature for vaccination syringes. Its primary function is to deliver precise medication doses while incorporating an auto-disable mechanism to prevent reuse, thereby reducing the risk of bloodborne pathogen transmission.
This syringe is intended for use in general hospital settings, including large-scale and routine immunization programs. Supplied as a sterile, single-use device, it is not intended for reuse or reprocessing. The product is authorized under FDA 510(k) clearance (K201234) and adheres to traditional review standards. No MRI safety or reusable configurations are specified.
Frequently asked questions
What types of injections is the BD SoloShot Mini Syringe designed for, and why is the auto-disable feature important?
The BD SoloShot Mini Syringe is specifically designed for intramuscular or subcutaneous injections, commonly used in vaccination programs and general hospital settings. The auto-disable feature is critical because it prevents the syringe from being reused, which significantly reduces the risk of bloodborne pathogen transmission. Since it is a single-use device, this design ensures patient safety by eliminating the possibility of contamination from repeated use.
Is the BD SoloShot Mini Syringe reusable, and if not, how should it be handled after use?
No, the BD SoloShot Mini Syringe is explicitly intended for single-use only and is not designed for reuse or reprocessing. After use, it should be disposed of according to standard medical waste protocols to prevent accidental reuse and maintain infection control standards. The auto-disable mechanism further reinforces this limitation by making reuse physically impossible.
What storage conditions should be followed for the BD SoloShot Mini Syringe to maintain its sterility?
While the exact storage conditions aren’t detailed in the provided data, the syringe is supplied as a sterile, single-use device, so it should be stored in a clean, dry environment protected from contamination. Typically, such syringes are kept in their original packaging until use to preserve sterility. Always follow manufacturer guidelines or facility protocols for optimal storage.
How does the BD SoloShot Mini Syringe differ from standard syringes in terms of safety features?
Unlike standard syringes, the BD SoloShot Mini Syringe includes an auto-disable mechanism, which prevents the plunger from being retracted after use. This design feature ensures the syringe cannot be reused, reducing the risk of needle-stick injuries and bloodborne pathogen transmission. This is particularly important in high-volume settings like vaccination programs or hospitals, where infection control is paramount.
What regulatory pathway was followed for the FDA clearance of this syringe, and what does that mean for its use?
The BD SoloShot Mini Syringe received FDA 510(k) clearance (K201234) under the Traditional Review pathway, determined to be *substantially equivalent* to a legally marketed device. This means it meets FDA standards for safety and effectiveness as a vaccination syringe for intramuscular or subcutaneous use in general hospital settings. The clearance does not imply any additional clinical indications beyond what’s stated in the device description.
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 SoloShot™ Mini Syringe | BD, BD SoloShot™ Mini Syringe | BD, Becton Dickinson – Wikipedia, BD SoloShot Mini Syringe/ BD Auto Disable Syringe
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201234 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K201234 24 fields · synced Sep 20, 2026