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Safesnap Safety Syringe

by U.S. Medical Instruments, Inc. 510(k)

Active United States

510(k) K925039

Overview

The Safesnap Safety Syringe is a syringe, antistick device designed to reduce the risk of transmission of blood-borne diseases from accidental needle sticks in healthcare and home care settings. It is a single-use hypodermic syringe intended for general hospital use.

The device is supplied as a sterile, single-use product and is regulated under FDA 510(k) clearance K925039, with product code MEG and regulation number 880.5860. It was determined to be substantially equivalent to a predicate device and received traditional clearance on February 16, 1994.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925039 Date16 Feb 1994ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from U.S. Medical Instruments, Inc.

Questions

  • What is the Safesnap Safety Syringe used for?

    The Safesnap Safety Syringe is designed to reduce the risk of transmission of blood-borne diseases from accidental needle sticks in healthcare and home care settings by incorporating an antistick mechanism that activates after use.

  • Is the Safesnap Safety Syringe sterile and single-use?

    Yes, the device is supplied as a sterile, single-use product, meaning it is intended for one-time use only and should be discarded after each injection to maintain sterility and prevent cross-contamination.

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

    The Safesnap Safety Syringe received FDA 510(k) clearance under K925039, determined to be substantially equivalent to a predicate device, and was cleared via the traditional pathway on February 16, 1994.