Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Friatec AG — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
204 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982576 | FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, | Friatec AG | 1998-10-22 | 90 | 0 |
| K980630 | FRIALIT-2 CORABASE | Friatec AG | 1998-09-04 | 198 | 0 |
| K973924 | FRIOS BONESHIELD | Friatec AG | 1998-05-07 | 204 | 0 |
| K974628 | FRIALIT-2 PROTECT ABUTMENT | Friatec AG | 1998-03-11 | 90 | 0 |
| K974358 | FRIALIT -2 SCREW | Friatec AG | 1998-02-10 | 83 | 0 |
| K974359 | FRIALIT-2 CYLINDER | Friatec AG | 1998-02-10 | 83 | 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