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Yi Xin Sterile Syringe for Single Use

by Jiangxi Sanxin (Eversincere) Medical Devices Group

510(k) K050999

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 NumberK050999 Date2 Sep 2005ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0007-2024 FDA Class I initiated 8 Aug 2023
    • Ongoing Z-0006-2024 FDA Class I initiated 8 Aug 2023
    • Ongoing Z-0005-2024 FDA Class I initiated 8 Aug 2023

    There is a potential for blood backfill leakage and foreign material.

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  • Withdrawn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

Overview

AI-generated summary, 28 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 Yi Xin Sterile Syringe for Single Use is a manual, disposable, sterile device designed for fluid injection or withdrawal. It consists of a barrel and plunger mechanism and is operated by clinicians or patients in clinical or home settings.

This sterile, single-use syringe is supplied to prevent cross-contamination and contains no electronic components, software, or automated processing. It is FDA 510(k) cleared with product code FMF and K number K050999.

Other devices from Jiangxi Sanxin (Eversincere) Medical Devices Group

Questions

AI-generated answers, 28 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 Yi Xin Sterile Syringe for Single Use designed for?

    The Yi Xin Sterile Syringe is a manual, disposable device designed for fluid injection or withdrawal in clinical or home settings. It consists of a barrel and plunger mechanism and is intended for single-use to prevent cross-contamination.

  • How is the Yi Xin Sterile Syringe supplied?

    The syringe is supplied as a sterile, single-use device with no electronic components, software, or automated processing. It is designed to be used once and then discarded to maintain sterility and prevent contamination.

  • What is the regulatory status of the Yi Xin Sterile Syringe?

    The Yi Xin Sterile Syringe is FDA 510(k) cleared with product code FMF and K number K050999. It was determined to be substantially equivalent to predicate devices through a traditional clearance process reviewed by the General Hospital advisory committee.

  • Is the Yi Xin Sterile Syringe reusable?

    No, the Yi Xin Sterile Syringe is designed for single-use only. It is supplied as a sterile device to prevent cross-contamination and should not be reused, as reuse could compromise sterility and potentially lead to contamination or infection.