Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Promepla Sam — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
181 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 | 30 | 0 |
| K173734 | RocaJJ Soft Stents | Promepla Sam | 2018-03-12 | 96 | 0 |
| K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | Promepla Sam | 2016-02-09 | 181 | 0 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 | 116 | 0 |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda