Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stoelting Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012011 | MODIFICATION TO A620 EEG | Stoelting Co. | 2001-10-10 | 104 | 0 |
| K965006 | AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) | Stoelting Co. | 1997-02-05 | 51 | 0 |
| K952797 | AT53 DUAL CHANNEL EMG | Stoelting Co. | 1996-04-17 | 303 | 0 |
| K944615 | A620 EEG | Stoelting Co. | 1995-09-18 | 363 | 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