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Warming Liquid Personal Lubricant

by Pharmapac, LLC

510(k) K052974

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 NumberK052974 Date16 Dec 2005ClearedStatusActive

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  • Withdrawn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.

This device is a personal lubricant intended to provide warmth during use. It is classified as a Class II medical device under the FDA 510(k) pathway.

It was found substantially equivalent to a predicate device and received traditional clearance on December 16, 2005. The device is supplied non-sterile and is intended for single use in obstetrics and gynecology settings.

Other devices from Pharmapac, LLC

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 the Warming Liquid Personal Lubricant used for?

    It is intended to provide warmth during use in obstetrics and gynecology settings, as stated in its FDA 510(k) clearance documentation.

  • How is the Warming Liquid Personal Lubricant supplied and is it sterile?

    The device is supplied non-sterile and is intended for single use only, based on its labeling and clearance details.

  • What regulatory pathway was used for the Warming Liquid Personal Lubricant?

    It received traditional FDA 510(k) clearance on December 16, 2005, under K052974, after being found substantially equivalent to a predicate device.