Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stuart — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
176 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | 1990-06-21 | 176 | 0 |
| K890601 | STUART TITANIUM SURGICAL MESH | Stuart | 1989-03-16 | 38 | 0 |
| K851414 | SEGMENTAL SPINAL RODS | Stuart | 1985-06-28 | 80 | 0 |
| K843445 | SACRAL BAR | Stuart | 1985-02-13 | 161 | 0 |
| K820034 | ANTERIOR DISTRACTION SYSTEM | Stuart | 1982-03-11 | 66 | 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