Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Labotect Labor-Technik Gottingen — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021438 | INSEMINATION CATHETER, MODEL 320301 | Labotect Labor-Technik Gottingen | 2002-07-16 | 71 | 0 |
| K003056 | OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200- | Labotect Labor-Technik Gottingen | 2000-12-13 | 73 | 0 |
| K000950 | EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 | Labotect Labor-Technik Gottingen | 2000-05-12 | 50 | 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