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BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

by Becton, Dickinson and Company

510(k) K252506Ref 368383, 367288, 367286, 367295

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252506↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038290SZEOSWRES3 Basic UDI-DI Date12 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252506 Date10 Apr 2026ClearedStatusActive
United StatesGUDID listing GUDID Number30382903672883 UDI-DI Date2 Apr 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0777-2007 FDA Unclassified (pre-2012) initiated 20 Mar 2007

    The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Vacutainer Safety-Lok EUDAMED
BD Vacutainer® Safety-Lok™ Blood Collection Set GUDID
Generic Name
Blood collection set, invasive
Model / Ref / Catalog
367288, 368383, 367286, 367295
Primary DI / UDI-DI
30382903672883, 30382903683834, 30382903672869, 30382903672951
Basic UDI-DI
038290SZEOSWRES3
Unit of Use DI
00382903683833, 00382903672882, 00382903672868, 00382903672950
510(k) Number
FDA Product Code
JKA
EMDN Code
A01010201 Butterfly needles, with safety systems
GMDN Term
Blood collection set, invasive
Models / Variants
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 862.1675
EU market of registration
Belgium
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
—
510(k)
K252506
GUDID
K980414
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

From the manufacturer

BD Vacutainer® Safety-Lok™ Blood Collection Set 23 G x .75 in. with 12 in. tubing and pre-attached holder in a fully sterilized package Offering an integrated device that may simplify the phlebotomy procedure.

Source: bd.com

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Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No