Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Levtech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
212 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910128 | LEVTECH TITANIUM BONE WIRE | Levtech, Inc. | 1991-06-18 | 160 | 0 |
| K901144 | LEVTECH BONE SCREW | Levtech, Inc. | 1990-10-10 | 212 | 0 |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | Levtech, Inc. | 1988-02-05 | 144 | 0 |
| K874023 | LEVTECH CLAMP APPLIER | Levtech, Inc. | 1987-11-06 | 35 | 0 |
| K850039 | HALIFAX SPINAL CLAMP | Levtech, Inc. | 1985-05-29 | 142 | 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