Skip to content

Retrax Safety Syringe

by Retrax, Inc.

510(k) K901508

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 NumberK901508 Date14 Jun 1990ClearedStatusActive

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  • Withdrawn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
FMF
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.

The Retrax Safety Syringe is a piston syringe intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle.

The device is supplied in a 3CC size and is authorized under FDA 510(k) clearance number K901508 with product code FMF. It was determined to be substantially equivalent on June 14, 1990, and is manufactured by Retrax, Inc.

Other devices from Retrax, Inc.

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 Retrax Safety Syringe used for?

    The Retrax Safety Syringe is a piston syringe intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. It features a male connector at one end for fitting the female connector of a hypodermic single lumen needle.

  • What sizes and models of the Retrax Safety Syringe are available?

    The Retrax Safety Syringe is supplied in a 3CC size. This is the only size available for this particular model, which is distinguished by its FDA 510(k) clearance number K901508 and product code FMF.

  • What is the regulatory status of the Retrax Safety Syringe?

    The Retrax Safety Syringe is authorized under FDA 510(k) clearance number K901508 with product code FMF. It was determined to be substantially equivalent on June 14, 1990, and is manufactured by Retrax, Inc.

  • Is the Retrax Safety Syringe single-use or reusable?

    The device description does not specify whether the Retrax Safety Syringe is single-use or reusable. However, as it is intended for medical purposes and connects with hypodermic needles, it is likely designed for single-use applications to ensure safety and prevent cross-contamination.