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BD SafetyGlide 303330

by Becton, Dickinson and Company

BD SafetyGlide 303330 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K951254 on 7 Oct 1995 and listed in FDA GUDID since 2 Sep 2023 (UDI-DI 00382903033300), active as of 26 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

510(k) K951254

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382903033300 UDI-DI Date2 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951254 Date7 Oct 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951254 decided 7 Oct 1995 Active
  • FDA GUDID UDI-DI 00382903033300 listed 2 Sep 2023 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

6 dated events

  1. Cleared FDA 510(k) K951254
  2. Recall initiated FDA recalls Z-2748-2017
  3. Recall initiated FDA recalls Z-3116-2017
  4. Recall initiated FDA recalls Z-0315-2018
  5. Recall initiated FDA recalls Z-2889-2020
  6. Listed FDA GUDID 00382903033300

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BD SafetyGlide
Generic name
General-purpose syringe/needle
Model / Ref / Catalog
303330
Primary DI / UDI-DI
00382903033300
510(k) Number
FDA product code
FMI, FMF
GMDN term
General-purpose syringe/needle
Device class
Class II
Regulation number
880.5570, 880.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter
Length — 0.038 Inch

Related devices

Category: General-purpose syringe/needle

Cleared under the same submission (K951254)

and 8 more cleared under K951254

Similar devices in this category

Other devices filed under General-purpose syringe/needle.

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)