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SAFE-1 Syringe

by Safety 1st Medical, Inc.

510(k) K940635

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 NumberK940635 Date31 Jan 1995ClearedStatusActive

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  • Withdrawn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)

Full name
Safe-1(Tm) Syringe
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, 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 Safe-1 Syringe is a piston syringe intended for medical purposes. It consists of a calibrated hollow barrel and a movable plunger, featuring a male connector nozzle at one end designed to fit the female hub of a hypodermic single lumen needle. This device is used to inject fluids into, or withdraw fluids from, the body.

This device is identified by K-number K940635 and has received FDA 510(k) clearance. It is categorized under product code FMF and is classified as a class 2 medical device. Further details regarding specific storage, sterility, or reuse instructions are not provided in the available regulatory data.

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 function of the Safe-1 Syringe?

    The Safe-1 Syringe is a piston-style device consisting of a calibrated barrel and a movable plunger. It is intended for medical use to inject fluids into or withdraw fluids from the human body.

  • How does the Safe-1 Syringe connect to other medical equipment?

    The device features a male connector nozzle located at one end of the barrel. This nozzle is specifically designed to fit securely into the female hub of a standard hypodermic single lumen needle.

  • What is the regulatory status of this device?

    The Safe-1 Syringe is a class 2 medical device that has received FDA 510(k) clearance under K-number K940635. It is categorized under product code FMF and was determined to be substantially equivalent to existing devices.