BD Safety-Lok 305564
by Becton, Dickinson and Company
BD Safety-Lok 305564 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K944757 on 11 Jan 1995 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 30382903055648), active as of 26 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30382903055648 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944757 | Date11 Jan 1995 | StatusActive |
Official records
- AccessGUDID record 30382903055648
- FDA 510(k) database K944757
Across registries
- FDA 510(k) K944757 decided 11 Jan 1995 Active
- FDA GUDID UDI-DI 30382903055648 listed 19 Sep 2016 Listed
Recalls
-
- Terminated Z-2008-2019
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Timeline
- Cleared FDA 510(k) K944757
- Listed FDA GUDID 30382903055648
- Recall initiated FDA recalls Z-2008-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BD Safety-Lok
- Generic name
- General-purpose syringe, single-use
- Model / Ref / Catalog
- 305564
- Primary DI / UDI-DI
- 30382903055648
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- General-purpose syringe, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose syringe, single-use.