Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DYC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023414 | MIDA ALGORITHM REV. B | Ortivus AB | 2003-12-05 | 420 | 0 |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | Medical Graphics Corp. | 1990-01-18 | 73 | 0 |
| K823934 | CARIEL F12 | Odam | 1983-12-16 | 352 | 0 |
| K810529 | DIRECT WRITING VECTORCARDIOGRAPH | Elmed, Inc. | 1981-04-23 | 56 | 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