Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mtd, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063439 | MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS | Mtd, Inc. | 2007-01-22 | 70 | 0 |
| K833559 | ARMBOARD | Mtd, Inc. | 1984-01-03 | 90 | 0 |
| K791374 | THE MTD VARA SET CASETTE HOLDER | Mtd, Inc. | 1979-09-07 | 45 | 0 |
| K772321 | ARTHROSTRESS | Mtd, Inc. | 1978-01-03 | 15 | 0 |
| K771659 | PATIENT RESTRAINT SYSTEM | Mtd, Inc. | 1977-09-30 | 31 | 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