Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KLX · 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) |
|---|---|---|---|---|---|
| K990240 | ELECTROGLOTTOGRAPH | Kay Elemetrics Corp. | 1999-03-11 | 45 | 0 |
| K901609 | ELECTROGLOTTOGRAPH | Glottal Ent., Inc. | 1990-06-28 | 83 | 0 |
| K841832 | GLOTTAL FREQUENCY ANALYSER | Teltec Electronic Equipment AB | 1984-07-18 | 76 | 0 |
| K821079 | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | Ms. Kate Teaney | 1982-05-10 | 21 | 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