BD Safety-Lok 305902: CE/MDR Class IIa

Regulatory status

as of registry sync 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number038290SPLQSMSXPZ Basic UDI-DI 00382903059027UDI-DI	Date12 Aug 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00382903059027 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK951254	Date7 Oct 1995Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 038290SPLQSMSXPZ — open Devices and search for it
AccessGUDID record UDI-DI 00382903059027
FDA 510(k) database 510(k) number K951254

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 038290SPLQSMSXPZ registered 12 Aug 2026 Active
FDA 510(k) K951254 decided 7 Oct 1995 Active
FDA GUDID UDI-DI 00382903059027 listed 16 Sep 2016 Listed

Recalls

4 recalls · FDA

- Terminated Z-2889-2020 FDA Class II initiated 28 Jul 2020
Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- Terminated Z-0315-2018 FDA Class II initiated 5 Jul 2017
Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.
- Terminated Z-3116-2017 FDA Class II initiated 13 Jun 2017
Presence of loose polypropylene foreign matter above release specification.
- Terminated Z-2748-2017 FDA Class II initiated 16 Sep 2016
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Timeline

7 dated events

7 Oct 1995 Cleared FDA 510(k) K951254
16 Sep 2016 Listed FDA GUDID 00382903059027
16 Sep 2016 Recall initiated FDA recalls Z-2748-2017
13 Jun 2017 Recall initiated FDA recalls Z-3116-2017
5 Jul 2017 Recall initiated FDA recalls Z-0315-2018
28 Jul 2020 Recall initiated FDA recalls Z-2889-2020
12 Aug 2026 Registered EUDAMED 038290SPLQSMSXPZ

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: SafetyGlide EUDAMED
BD Safety-Lok GUDID
Generic name: Hypodermic needle, single-use
Device name: BD SafetyGlide™ Needle (Sterile)
Model / Ref / Catalog: 305902

Primary DI / UDI-DI: 00382903059027
Basic UDI-DI: 038290SPLQSMSXPZ
510(k) Number: K951254
FDA product code: FMI
EMDN code: A0101010101 Hypodermic syringe needles, with safety systems
GMDN term: Hypodermic needle, single-use

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 880.5570
EU registration type: Standard device
EU market of registration: Spain
GUDID distribution status: In Commercial Distribution

Size: Length — 1 Inch
Needle Gauge — 23 Gauge

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.