Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ECO · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
381 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943068 | MAGNEFORCE | Ormco Corp. | 1994-08-17 | 50 | 0 |
| K933542 | MESIAL LOOP BAR | Gac Intl., Inc. | 1994-08-05 | 381 | 0 |
| K942492 | ADJUSTABLE BITE CORRECTOR | Orthoplus, Inc. | 1994-07-13 | 49 | 0 |
| K844234 | ACTIVE VERTICAL CORRECTOR APPLIANCE | Active Vertical Correctors, Inc. | 1985-01-04 | 64 | 0 |
| K843550 | ORTHOMAG MAGNETIC FORCE SYSTEM | Medical Magnetics, Inc. | 1984-12-21 | 102 | 0 |
| K843344 | ACTIVE VERTICAL CORRECTOR ACTIVE BITE | Active Vertical Correctors, Inc. | 1984-12-03 | 98 | 0 |
| K770558 | ISODYNE | Hmw Industries | 1977-04-05 | 14 | 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