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Microlance 301300

by Becton, Dickinson and Company

Microlance 301300 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K021475 on 19 Jul 2002 and listed in FDA GUDID since 1 Sep 2023 (UDI-DI 00382903013005), active as of 26 Oct 2026. 3 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

3 closed

Documents

510(k) K021475

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 Number00382903013005 UDI-DI Date1 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK021475 Date19 Jul 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021475 decided 19 Jul 2002 Active
  • FDA GUDID UDI-DI 00382903013005 listed 1 Sep 2023 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0588-2021 FDA Class II initiated 18 Nov 2020

    BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.

    • Terminated Z-0207-2018 FDA Class II initiated 31 May 2017

    Hub damage resulting in breakage and/or leakage during use.

    • Terminated Z-1009-2012 FDA Unclassified (pre-2012) initiated 8 Oct 2011

    Becton Dickinson has identified clogged needles.

Timeline

5 dated events

  1. Cleared FDA 510(k) K021475
  2. Recall initiated FDA recalls Z-1009-2012
  3. Recall initiated FDA recalls Z-0207-2018
  4. Recall initiated FDA recalls Z-0588-2021
  5. Listed FDA GUDID 00382903013005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Microlance
Generic name
Hypodermic needle, single-use
Model / Ref / Catalog
301300
Primary DI / UDI-DI
00382903013005
510(k) Number
FDA product code
FMI
GMDN term
Hypodermic needle, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hypodermic needle, single-use

Cleared under the same submission (K021475)

and 8 more cleared under K021475

Similar devices in this category

Other devices filed under Hypodermic needle, single-use.

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)