Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KTH · 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) |
|---|---|---|---|---|---|
| K962961 | SUSTAINED PHONATION | Surface Mount Technology, Inc. | 1996-09-09 | 41 | 0 |
| K942651 | BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS | Casa Futura Technologies | 1995-10-19 | 503 | 0 |
| K871590 | VOCALTECH VOCAL FEEDBACK DEVICE | Vocaltech C/O Hogan & Hartson | 1987-10-06 | 165 | 0 |
| K800445 | EDINBURGH MASKER | Foundation For Fluency, Inc. | 1980-03-12 | 13 | 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