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Perfect Safety Syringe

by Perfect Medical Industry Co., Ltd.

510(k) K030604

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 NumberK030604 Date30 Apr 2004ClearedStatusActive

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  • Withdrawn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, 19 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 Perfect Safety Syringe is a manual medical device classified as a Syringe, Antistick (OpenFDA: MEG). It is designed to facilitate intramuscular (IM) and subcutaneous (SC) injections while incorporating a safety mechanism to minimize the risk of needlestick injuries. The device features a breakable plunger to prevent reuse, enhancing both safety and compliance with single-use protocols.

This syringe is intended for use in clinical settings by healthcare providers. It is supplied as a single-use, non-sterile device (as indicated by the absence of sterility claims in the data) and is not intended for MRI environments. Multiple sizes are available, as evidenced by the extensive list of registration numbers. The device holds an FDA 510(k) clearance (K030604) under the classification of Class II (880.5860) and is distributed by Perfect Medical Industry Co., Ltd.

Questions

AI-generated answers, 19 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 Perfect Safety Syringe intended for?

    The Perfect Safety Syringe is designed to facilitate intramuscular (IM) and subcutaneous (SC) injections while incorporating a safety mechanism to minimize the risk of needlestick injuries. It is intended for use by healthcare providers in clinical settings.

  • Is the Perfect Safety Syringe supplied sterile or non-sterile?

    The Perfect Safety Syringe is supplied as a single-use, non-sterile device, as indicated by the absence of sterility claims in the device data. It is not intended for reuse due to its breakable plunger feature.

  • How is the Perfect Safety Syringe designed to prevent reuse?

    The Perfect Safety Syringe features a breakable plunger mechanism that prevents reuse after a single injection, enhancing safety and supporting compliance with single-use protocols in clinical environments.

  • What regulatory pathway was used for the Perfect Safety Syringe?

    The Perfect Safety Syringe received FDA 510(k) clearance under submission number K030604, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation 880.5860.

  • What sizes or models are available for the Perfect Safety Syringe?

    Multiple sizes of the Perfect Safety Syringe are available, as evidenced by the extensive list of registration numbers and FEI numbers associated with the device, though specific volume capacities are not detailed in the provided data.