Promepla Sam: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Promepla Sam” (first 2012, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 116 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 |
|---|---|---|
| 2012 | 1 | 116 |
| 2013 | 0 | — |
| 2014 | 1 | 116 |
| 2015 | 0 | — |
| 2016 | 1 | 181 |
| 2017 | 0 | — |
| 2018 | 2 | 63 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 Promepla Sam took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | 3 | 3 |
| FAD | Stent, Ureteral | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
Most recent Promepla Sam 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182144 | Bi-Flex Evo | KNY | 2018-09-07 | 30 |
| K173734 | RocaJJ Soft Stents | FAD | 2018-03-12 | 96 |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | OCX | 2016-02-09 | 181 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | KNY | 2014-06-17 | 116 |
| K120160 | ROCAMED ROCAUS PLATINUM | KNY | 2012-05-14 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Promepla Sam.
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.
- Promepla (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Promepla Sam?
FDA lists 5 510(k) clearances under the applicant name “Promepla Sam” (first 2012, latest 2018), across 3 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 Promepla Sam?
The median time from FDA receipt to decision across 510(k)s cleared under the name Promepla Sam is 116 days.
Which FDA product codes appear under Promepla Sam?
The most frequent FDA product codes under this applicant name are KNY (Accessories, Catheter, G-U, 3); FAD (Stent, Ureteral, 1); OCX (Endoscopic Irrigation/Suction System, 1).
Next steps
- See all 5 Promepla Sam clearances with predicates and recalls
- Run predicate analysis for product code KNY, Promepla Sam'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.