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Instead Intimate Lubricant

by Instead, Inc.

510(k) K033776

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 NumberK033776 Date25 Jun 2004ClearedStatusActive

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  • Withdrawn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
NUC
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
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.

Instead Intimate Lubricant is a water-glycerin based personal lubricant formulated without fragrances or petroleum-based chemicals. It is designed to enhance comfort during sexual activity and is compatible with latex and polyurethane condoms.

The device is supplied as a Class II personal lubricant with FDA 510(k) clearance (K033776) under product code NUC. It is regulated under 884.5300 and was reviewed by the Obstetrics/Gynecology advisory committee. The device is substantially equivalent to other lubricants on the market.

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 Instead Intimate Lubricant formulated with?

    Instead Intimate Lubricant is a water-glycerin based personal lubricant that is formulated without fragrances or petroleum-based chemicals, making it gentle for intimate use.

  • Is Instead Intimate Lubricant compatible with condoms?

    Yes, Instead Intimate Lubricant is compatible with both latex and polyurethane condoms, making it safe for use with barrier protection methods.

  • What is the regulatory status of Instead Intimate Lubricant?

    Instead Intimate Lubricant is a Class II personal lubricant with FDA 510(k) clearance (K033776) under product code NUC, regulated under 884.5300 and reviewed by the Obstetrics/Gynecology advisory committee.

  • How is Instead Intimate Lubricant supplied?

    Instead Intimate Lubricant is supplied as a Class II personal lubricant in its standard packaging, designed for personal use to enhance comfort during sexual activity.