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K-Y Brand Warming Liquid

by Personal Products Co.

510(k) K070545

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 · Special NumberK070545 Date23 Mar 2007ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

K-Y Brand Warming Liquid is a personal lubricant device classified under product code NUC. It is a non-sterile, clear, non-staining, non-greasy, high-viscosity liquid gel intended for topical application to vaginal, anal, or penile tissue to provide lubrication and moisturization during intimate sexual activity.

The device is supplied as a non-sterile, single-use liquid gel in various sizes, including 1 oz containers. It is marketed for over-the-counter use and has received FDA 510(k) clearance (K070545) under regulation number 884.5300, with a special clearance type and substantially equivalent decision. Storage and handling should follow manufacturer guidelines for non-sterile personal lubricants.

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Questions

AI-generated answers, 21 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 K-Y Brand Warming Liquid used for?

    K-Y Brand Warming Liquid is intended for topical application to vaginal, anal, or penile tissue to provide lubrication and moisturization during intimate sexual activity, as stated in its device description.

  • How is K-Y Brand Warming Liquid supplied and is it sterile or single-use?

    The device is supplied as a non-sterile, single-use liquid gel in various sizes, including 1 oz containers, meaning it is not sterile and designed for one-time use only.

  • What are the storage and handling requirements for K-Y Brand Warming Liquid?

    Storage and handling should follow the manufacturer's guidelines for non-sterile personal lubricants, as specified in the device data, though specific conditions like temperature or light exposure are not detailed in the provided information.