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Condoms (Ramses Extra, Sheik Elite and Koromex)

by Schmid Laboratories, Inc.

510(k) K874791

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 NumberK874791 Date12 Apr 1988ClearedStatusActive

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  • Withdrawn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
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Condoms are barrier devices intended to prevent pregnancy and reduce the risk of sexually transmitted infections. This product includes the Ramses Extra, Sheik Elite, and Koromex condom models.

These condoms are supplied non-sterile for single-use in general healthcare and personal settings. They are classified as Class II medical devices under FDA regulation 884.5300 with product code HIS, and were cleared via the 510(k) pathway under K874791.

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