510(k) Report

FDA applicant

CC Wellness, LLC

Valencia, CA12 decisions2020–20230 recalls

FDA records 12 decisions for CC Wellness, LLC (Valencia, CA) from 2020 to 2023: 12 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and PEB (Lubricant, Personal, Gamete, Fertilization…). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided CC Wellness, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2020: 42021: 22022: 32023: 3
2020high 4 (2020) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — CC Wellness, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like CC Wellness, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NUCLubricant, Personal10decisions
  • PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2decisions

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 159 days; 10 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200208Agape Warming Personal LubricantCC Wellness, LLC · 20204cite it
  • K200894Agape Cooling Personal LubricantCC Wellness, LLC · 20201cites it
  • K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantCC Wellness, LLC · 20201cites it

What has FDA decided for it lately?

  • K232091JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC · 2023
  • K232090JO Coconut Hybrid Warming Personal LubricantCC Wellness, LLC · 2023
  • K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO…CC Wellness, LLC · 2023
  • K221908JO CUMPLAY Personal LubricantCC Wellness, LLC · 2022
  • K212885Actively Trying Personal Lubricant Rose ScentedCC Wellness, LLC · 2022
  • K212705Actively Trying Personal Lubricant UnfragranceCC Wellness, LLC · 2022
  • K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango…CC Wellness, LLC · 2021
  • K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife…CC Wellness, LLC · 2021

All 12 as CC Wellness, LLC →