Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heinz Kurz — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
74 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 10 | Heinz Kurz | 2001-03-08 | 22 | 0 |
| K991324 | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FE | Heinz Kurz | 1999-05-18 | 29 | 0 |
| K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 | Heinz Kurz | 1999-03-31 | 12 | 0 |
| K973356 | K-PISTON WITH BAND HOOK /ANGULAR PISTON | Heinz Kurz | 1997-11-21 | 74 | 0 |
| K972492 | BELL PROSTHESIS (PARTIAL) | Heinz Kurz | 1997-08-04 | 33 | 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