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Pre' Vaginal Lubricant

by Ingfertlity, LLC

510(k) K051436

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK051436 Date13 Oct 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0626-2009 FDA Unclassified (pre-2012) initiated 22 Sep 2008 on shared 510(k) K051436

    Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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