Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eckert & Ziegler Bebig 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) |
|---|---|---|---|---|---|
| K141900 | SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDIN | Eckert & Ziegler Bebig GmbH | 2015-05-20 | 310 | 1 |
| K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | 2015-04-17 | 183 | 0 |
| K140849 | ISOSEED | Eckert & Ziegler Bebig GmbH | 2014-07-02 | 90 | 0 |
| K123263 | HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS | Eckert & Ziegler Bebig GmbH | 2013-04-04 | 168 | 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