Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Resorba Medical GmbH · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181320 | Caprolon | Resorba Medical GmbH | 2018-09-18 | 123 | 0 |
| K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | Resorba Medical GmbH | 2015-11-02 | 319 | 0 |
| K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMID | Resorba Medical GmbH | 2015-10-29 | 315 | 0 |
| K141072 | SUPOLENE | Resorba Medical GmbH | 2014-06-23 | 59 | 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