Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

PEB — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

223 daysmedian FDA review time

499 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212885	Actively Trying Personal Lubricant Rose Scented	CC Wellness, LLC	2022-02-11	154	0
K212705	Actively Trying Personal Lubricant Unfragrance	CC Wellness, LLC	2022-02-09	167	0
K193450	Pre-Seed™ Fertility Lubricant	Church & Dwight Co., Inc.	2020-07-23	223	0
K190872	BioGenesis Fertility Lubricant	Good Clean Love, Inc.	2019-11-07	218	0
K182585	JO Actively Trying Personal Lubricant	United Consortium	2019-04-26	218	0
K162319	BabyDance Fertility Lubricant	Fairhaven Health, LLC	2017-04-28	252	0
K141132	ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT	Biofilm, Inc.	2015-01-09	253	0
K131355	CONCEIVE PLUS	Sasmar, Inc.	2013-11-07	181	0
K072741	PRE-VA VAGINAL LUBRICANT	Ingfertility, LLC	2008-07-16	293	0
K051436	PRE' VAGINAL LUBRICANT	Ingfertlity, LLC	2006-10-13	499	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda