Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Graftys — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
197 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231714 | Graftys Quickset | Graftys | 2023-07-12 | 30 | 0 |
| K093343 | GRAFTY QUICKSET | Graftys | 2010-04-22 | 178 | 0 |
| K082498 | GRAFTYS HBS | Graftys | 2009-02-25 | 180 | 0 |
| K082286 | BIOACTYS | Graftys | 2009-02-24 | 197 | 0 |
| K073064 | GRAFTYS BCP | Graftys | 2008-03-11 | 133 | 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