Atlas FDA

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

CC Wellness, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time
154 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232091JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC2023-10-221010
K232090JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC2023-10-11900
K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO WateCC Wellness, LLC2023-05-08590
K221908JO CUMPLAY Personal LubricantCC Wellness, LLC2022-09-20820
K212885Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC2022-02-111540
K212705Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC2022-02-091670
K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal LuCC Wellness, LLC2021-06-10700
K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal LuCC Wellness, LLC2021-06-10710
K200894Agape Cooling Personal LubricantCC Wellness, LLC2020-07-02900
K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubCC Wellness, LLC2020-06-03860
K200457Premium Warming Personal Lubricant, Premium Anal Warming LubCC Wellness, LLC2020-05-22870
K200208Agape Warming Personal LubricantCC Wellness, LLC2020-04-27900

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