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Fortuna Disposable Syringes

by Impor-Tex, Intl., Inc.

510(k) K851519

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 NumberK851519 Date17 Jun 1985ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Fortuna Disposable Syringes are medical devices designed for single-use applications. These syringes are manufactured by Impor-Tex, Intl., Inc. and are part of the FMF product code category.

The device is supplied as a disposable product and is not intended for reuse. It received FDA 510(k) clearance on June 17, 1985, with the K number K851519. The device is designed for general hospital use and is not MRI compatible.

Questions

AI-generated answers, 23 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 are Fortuna Disposable Syringes used for?

    Fortuna Disposable Syringes are designed for single-use applications in general hospital settings. They are not intended for reuse and are not MRI compatible.

  • How are Fortuna Disposable Syringes supplied?

    These syringes are supplied as disposable products, meaning they are designed for single-use only and should not be reused after administration.

  • What is the regulatory status of Fortuna Disposable Syringes?

    Fortuna Disposable Syringes received FDA 510(k) clearance on June 17, 1985, with K number K851519. They are classified under product code FMF and are considered substantially equivalent to predicate devices.

  • Who manufactures Fortuna Disposable Syringes?

    Fortuna Disposable Syringes are manufactured by Impor-Tex, Intl., Inc., located in Richardson, Texas. The company has been producing these medical devices since receiving clearance in 1985.