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Ved Valu- Vacuum Erection Device

by Mission Pharmacal Comp

510(k) K980948

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 NumberK980948 Date25 Jun 1998ClearedStatusActive

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  • Withdrawn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
LKY
Device Class
Class II
Regulation
21 CFR Part 876.5020
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The VED Valu-Vacuum Erection Device is a Vacuum Erection Device (VED), classified under FDA regulation 876.5020. It is designed to create penile rigidity through a vacuum mechanism, aiding in the treatment of erectile dysfunction by drawing blood into the penis to achieve and maintain an erection.

This device is supplied as a reusable medical instrument, intended for clinical use in urology settings. It requires no sterilisation between uses but must be cleaned and maintained according to manufacturer guidelines. The device is not MRI-safe and is available in a single configuration as referenced by product code LKY. It was granted FDA 510(k) clearance under the Traditional pathway, with a decision date of June 25, 1998.

Questions

AI-generated answers, 1 Oct 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 Valu-Vacuum Erection Device (LKY) used for?

    The Valu-Vacuum Erection Device (LKY) is designed to treat erectile dysfunction by generating penile rigidity through a vacuum mechanism. It works by drawing blood into the penis, helping to achieve and maintain an erection for clinical use in urology settings.

  • Is the Valu-Vacuum Erection Device (LKY) reusable or single-use?

    The Valu-Vacuum Erection Device (LKY) is a reusable medical instrument. While it does not require sterilization between uses, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper function and hygiene.

  • What safety considerations should be noted when using the Valu-Vacuum Erection Device (LKY)?

    The Valu-Vacuum Erection Device (LKY) is not MRI-safe, meaning it should not be used in or near MRI machines. Always follow the manufacturer’s instructions for cleaning, maintenance, and usage to ensure safe and effective operation.

  • Are there different sizes or models available for the Valu-Vacuum Erection Device?

    The Valu-Vacuum Erection Device (LKY) is available in a single configuration, identified by the product code LKY. There are no additional sizes or models listed for this specific device.

  • What regulatory pathway was followed for the FDA clearance of the Valu-Vacuum Erection Device?

    The Valu-Vacuum Erection Device received FDA 510(k) clearance under the Traditional pathway, with a decision date of June 25, 1998. It was classified as substantially equivalent to a predicate device and reviewed by the Gastroenterology and Urology Advisory Committee.