Rb Health (Us), LLC: FDA clearances and approvals
Rb Health (Us), LLC has 15 FDA 510(k) clearances (first 2019, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 150 days. Since 2017 its median was 150 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 145 |
| 2020 | 4 | 172 |
| 2021 | 1 | 88 |
| 2022 | 5 | 134 |
| 2023 | 2 | 269 |
| 2024 | 0 | — |
| 2025 | 1 | 268 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Rb Health (Us), LLC's cleared 510(k)s took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 9 | 9 |
| HIS | Condom | 5 | 5 |
| MOL | Condom, Synthetic | 1 | 1 |
Review panels
Most recent Rb Health (Us), LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241617 | Durex Polyisoprene Condom | MOL | 2025-02-28 | 268 |
| K230781 | Belle Sensilube | NUC | 2023-06-20 | 90 |
| K213892 | Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine | NUC | 2023-03-07 | 448 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | HIS | 2022-11-07 | 258 |
| K222068 | Durex Penck III Regular | HIS | 2022-10-12 | 90 |
| K211152 | Durex Condom with Benzocaine | HIS | 2022-05-11 | 387 |
| K213400 | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry | NUC | 2022-03-01 | 134 |
| K213647 | Durex Patronus Wide | HIS | 2022-02-17 | 90 |
| K211088 | Grosz Play Feel | NUC | 2021-07-09 | 88 |
| K200672 | Durex Penck Standard, Durex Penck XL | HIS | 2020-11-06 | 238 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rb Health (Us), LLC.
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 Rb Health (Us), LLC have?
Rb Health (Us), LLC has 15 FDA 510(k) clearances (first 2019, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Rb Health (Us), LLC's 510(k)s?
The median time from FDA receipt to decision across Rb Health (Us), LLC's cleared 510(k)s is 150 days. Since 2017: 150 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Rb Health (Us), LLC make?
Its most frequent FDA product codes are NUC (Lubricant, Personal, 9); HIS (Condom, 5); MOL (Condom, Synthetic, 1).
Has Rb Health (Us), LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Rb Health (Us), LLC. Related entities may recall under other names.
Next steps
- See all 15 Rb Health (Us), LLC clearances with predicates and recalls
- Run predicate analysis for product code NUC, Rb Health (Us), LLC'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.