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Sterile Auto-Disable Syringes with/without Needle for Single Use

by Zhejiang Kangkang Medical-Devices Co., Ltd.

510(k) K210229

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 NumberK210229 Date15 Feb 2022ClearedStatusActive

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  • Withdrawn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
MEG
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

This device is a sterile auto-disable syringe, with or without a needle, intended for single use. It is classified as a syringe, antistick, under FDA product code MEG and regulation number 880.5860, and is designed for general hospital use.

The syringe is supplied sterile and is for single-use only. It received FDA 510(k) clearance (K210229) on February 15, 2022, as substantially equivalent to a predicate device, and is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd. in Yuhuan, China.

Other devices from Zhejiang Kangkang Medical-Devices Co., Ltd.

See all devices from Zhejiang Kangkang Medical-Devices Co., Ltd. →

Questions

AI-generated answers, 26 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 Sterile Auto-Disable Syringe with/without Needle for Single Use intended for?

    This device is intended for general hospital use as a sterile, single-use syringe with an auto-disable feature to prevent reuse. It is designed for administering medications or vaccines safely, reducing the risk of needlestick injuries and cross-contamination after one use.

  • Is the Sterile Auto-Disable Syringe supplied sterile and for single use only?

    Yes, the syringe is supplied in a sterile condition and is explicitly designed for single-use only. The auto-disable mechanism ensures the plunger locks after full depression, preventing any attempt to reuse the device, which supports infection control protocols in clinical environments.

  • What regulatory pathway was used for the Sterile Auto-Disable Syringe with/without Needle for Single Use?

    The device received FDA 510(k) clearance under submission number K210229 on February 15, 2022, as substantially equivalent to a predicate device. It is classified under FDA product code MEG and regulation number 880.5860 for syringes, antistick.