Atlas FDA

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

United Consortium — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time
218 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192203JO for Him H2O Gel Original Personal LubricantUnited Consortium2020-02-101800
K190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone LuUnited Consortium2019-09-181690
K191214JO Premium Jelly Original Personal LubricantUnited Consortium2019-08-01870
K182585JO Actively Trying Personal LubricantUnited Consortium2019-04-262180
K183584JO H2O Jelly Original Personal LubricantUnited Consortium2019-04-171170
K183384JO Agape Original Personal Lubricant, MUSE Essence Water-BasUnited Consortium2019-03-04880
K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry FUnited Consortium2018-11-141030
K181408JO Classic Hybrid Personal LubricantUnited Consortium2018-08-27890
K180712Coconut Infused Hybrid Personal LubricantUnited Consortium2018-06-06790
K180219JO H2O Flavored Personal LubricantsUnited Consortium2018-04-20850
K180083Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium2018-04-09880
K172447JO Gelato Flavored Personal LubricantsUnited Consortium2017-10-31780
K171021JO Agapé Personal LubricantUnited Consortium2017-07-181040
K132954JO PREMIUM PERSONAL LUBRICANTUnited Consortium2014-06-112640

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