United Consortium: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “United Consortium” (first 2014, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Since 2017 the median was 89 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 |
|---|---|---|
| 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, 510(k)s cleared under the name United Consortium 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 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Consortium?
FDA lists 15 510(k) clearances under the applicant name “United Consortium” (first 2014, latest 2020), 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 United Consortium?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Consortium is 103 days. Since 2017: 89 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under United Consortium?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 14); PEB (Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, 1).
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. 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.