CC Wellness, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “CC Wellness, LLC” (first 2020, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 146 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 4 | 88 |
| 2021 | 2 | 70 |
| 2022 | 3 | 154 |
| 2023 | 3 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CC Wellness, LLC took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 10 | 10 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 2 | 2 |
Review panels
Most recent CC Wellness, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232091 | JO Coconut Hybrid Cooling Personal Lubricant | NUC | 2023-10-22 | 101 |
| K232090 | JO Coconut Hybrid Warming Personal Lubricant | NUC | 2023-10-11 | 90 |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | NUC | 2023-05-08 | 59 |
| K221908 | JO CUMPLAY Personal Lubricant | NUC | 2022-09-20 | 82 |
| K212885 | Actively Trying Personal Lubricant Rose Scented | PEB | 2022-02-11 | 154 |
| K212705 | Actively Trying Personal Lubricant Unfragrance | PEB | 2022-02-09 | 167 |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit | NUC | 2021-06-10 | 70 |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two | NUC | 2021-06-10 | 71 |
| K200894 | Agape Cooling Personal Lubricant | NUC | 2020-07-02 | 90 |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant | NUC | 2020-06-03 | 86 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named CC Wellness, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under CC Wellness, LLC?
FDA lists 12 510(k) clearances under the applicant name “CC Wellness, LLC” (first 2020, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by CC Wellness, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name CC Wellness, LLC is 88 days. Since 2017: 88 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CC Wellness, LLC?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 10); PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, 2).
Next steps
- See all 12 CC Wellness, LLC clearances with predicates and recalls
- Run predicate analysis for product code NUC, CC Wellness, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.