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INSTINCT - Plain, Dotted, Ultra Thin

by Profilatex, S.A. DE C.V.

510(k) K132390

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 · Abbreviated NumberK132390 Date22 Apr 2014ClearedStatusActive

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  • Withdrawn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
Models / Variants
Plain, Dotted, Ultra Thin
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
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 Instinct Condom; Plain, Dotted, Ultra Thin is a barrier contraceptive device classified as a condom. It is designed to prevent pregnancy and reduce the risk of sexually transmitted infections by providing a physical barrier between partners during sexual intercourse. This product is available in three distinct styles—plain, dotted, and ultra-thin—each intended for general contraceptive use.

These condoms are supplied as single-use, non-sterile products and are intended for use in the setting of sexual health and contraception. They are manufactured in various sizes and textures, as indicated by their respective styles, and must be stored in a cool, dry place away from direct sunlight. The device holds an FDA 510(k) clearance under the classification of Class II medical devices, with the advisory committee designation for Obstetrics/Gynecology.

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 Instinct Ultra Thin Condom used for?

    The Instinct Ultra Thin Condom is a barrier contraceptive designed to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs) by creating a physical barrier between partners during sexual intercourse. Its ultra-thin design is intended for general contraceptive use while maintaining effectiveness.

  • How is the Instinct Condom supplied and what are its key features?

    The Instinct Condom is supplied as a single-use product and is non-sterile. It comes in three distinct styles—plain, dotted, and ultra-thin—each tailored for general contraceptive use. The ultra-thin variant is specifically designed for a delicate feel while maintaining barrier protection.

  • Is the Instinct Condom reusable or single-use?

    The Instinct Condom is explicitly designed for single-use only. This ensures hygiene and safety, as reuse could compromise its protective integrity and increase the risk of infection or contraceptive failure.

  • What storage conditions are required for the Instinct Condom?

    The Instinct Condom must be stored in a cool, dry place away from direct sunlight. Exposure to heat, moisture, or sunlight can degrade the material and compromise its effectiveness or integrity.

  • What regulatory approval does the Instinct Ultra Thin Condom hold?

    The Instinct Ultra Thin Condom holds FDA 510(k) clearance under the classification of Class II medical devices, with an advisory committee designation for Obstetrics/Gynecology. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for barrier contraceptives.