Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ELA · 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) |
|---|---|---|---|---|---|
| K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | Ela Medical, Inc. | 1995-08-15 | 106 | 0 |
| K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | Travenol Laboratories, S.A. | 1986-03-13 | 149 | 0 |
| K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Analytic Technology | 1980-11-12 | 85 | 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