Rolence Enterprise, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Rolence Enterprise, Inc.” (first 2018, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 282 days. 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 |
|---|---|---|
| 2018 | 1 | 172 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 392 |
| 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 Rolence Enterprise, Inc. took a median 282 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 66 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (2)
Most recent Rolence Enterprise, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202369 | RXS 1000 | MUH | 2021-09-15 | 392 |
| K172928 | Portable X-ray System | EHD | 2018-03-16 | 172 |
Recalls
openFDA lists no recalls under a recalling firm named Rolence Enterprise, Inc..
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.
- Rolence Enterprise Co. , Ltd. (12 510(k)s)
- Rolence Ent., Inc. (5 510(k)s)
- Rolence Enteprise, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rolence Enterprise, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Rolence Enterprise, Inc.” (first 2018, latest 2021), 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 Rolence Enterprise, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rolence Enterprise, Inc. is 282 days.
Which FDA product codes appear under Rolence Enterprise, Inc.?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 1); MUH (System, X-Ray, Extraoral Source, Digital, 1).
Next steps
- See all 2 Rolence Enterprise, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Rolence Enterprise, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.