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BD Contoured Base Pen Needle

by Becton, Dickinson and Company

510(k) K182320

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182320 Date20 Dec 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FMI
Device class
Class II
Regulation
21 CFR Part 880.5570
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD Contoured Base Pen Needle is a hypodermic needle designed specifically for subcutaneous drug delivery via pen injector devices. It features a 32G x 4mm cannula, a non-posted hub, an inner needle shield, and an outer cover, ensuring compatibility with insulin and other injectable medications.

This device is single-use, sterile, and disposable, intended for use by patients or caregivers in home or clinical settings. It is supplied in a sterile package and adheres to FDA 510(k) clearance (K182320) under the General Hospital advisory committee. No additional regulatory status beyond the stated clearance is implied.

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