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Insulin Pen Needle

by Wenzhou Beipu Science & Technology Co., Ltd.

510(k) K133059

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133059 Date25 Feb 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 27 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 Insulin Pen Needle is a medical device designed for the subcutaneous injection of insulin. It features an ultra-fine needle with a special cut and a silicon coating to facilitate the injection process.

This device is compatible with all major insulin pens available on the market and is available in sizes as thin as 34G and as short as 4mm. The product has received FDA 510k clearance.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the primary purpose of the Insulin Pen Needle?

    This device is specifically designed for the subcutaneous injection of insulin. It utilizes an ultra-fine needle with a special cut and a silicon coating to help facilitate a smoother injection process for the user.

  • Is this needle compatible with my insulin pen?

    The Insulin Pen Needle is designed to be compatible with all major insulin pens currently available on the market, ensuring broad utility for patients regardless of their specific pen device.

  • What size options are available for this needle?

    The needles are manufactured in various sizes to accommodate different patient needs, with options available as thin as 34G and as short as 4mm.

  • Has this device received regulatory clearance?

    Yes, the Insulin Pen Needle has received FDA 510k clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.