United Consortium: FDA clearances and approvals
United Consortium has 15 FDA 510(k) clearances (first 2014, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 103 days. Since 2017 its median was 89 days, against 146 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 264 |
| 2015 | 1 | 134 |
| 2016 | 0 | — |
| 2017 | 2 | 91 |
| 2018 | 5 | 88 |
| 2019 | 5 | 117 |
| 2020 | 1 | 180 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, United Consortium's cleared 510(k)s took a median 89 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 | 14 | 14 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 1 | 1 |
Review panels
Most recent United Consortium 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192203 | JO for Him H2O Gel Original Personal Lubricant | NUC | 2020-02-10 | 180 |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant | NUC | 2019-09-18 | 169 |
| K191214 | JO Premium Jelly Original Personal Lubricant | NUC | 2019-08-01 | 87 |
| K182585 | JO Actively Trying Personal Lubricant | PEB | 2019-04-26 | 218 |
| K183584 | JO H2O Jelly Original Personal Lubricant | NUC | 2019-04-17 | 117 |
| K183384 | JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant | NUC | 2019-03-04 | 88 |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | NUC | 2018-11-14 | 103 |
| K181408 | JO Classic Hybrid Personal Lubricant | NUC | 2018-08-27 | 89 |
| K180712 | Coconut Infused Hybrid Personal Lubricant | NUC | 2018-06-06 | 79 |
| K180219 | JO H2O Flavored Personal Lubricants | NUC | 2018-04-20 | 85 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named United Consortium.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does United Consortium have?
United Consortium has 15 FDA 510(k) clearances (first 2014, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear United Consortium's 510(k)s?
The median time from FDA receipt to decision across United Consortium's cleared 510(k)s is 103 days. Since 2017: 89 days, versus 146 days for all cleared 510(k)s in the same product codes.
What devices does United Consortium make?
Its most frequent FDA product codes are NUC (Lubricant, Personal, 14); PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, 1).
Has United Consortium had device recalls?
openFDA lists no recalls under a recalling firm name matching United Consortium. Related entities may recall under other names.
Next steps
- See all 15 United Consortium clearances with predicates and recalls
- Run predicate analysis for product code NUC, United Consortium's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.