Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dymedix, Inc. — 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) |
|---|---|---|---|---|---|
| K040069 | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR | Dymedix, Inc. | 2004-05-05 | 112 | 0 |
| K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 | Dymedix, Inc. | 2004-04-26 | 49 | 0 |
| K020468 | CHIN ELECTRODE | Dymedix, Inc. | 2002-04-16 | 63 | 0 |
| K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, | Dymedix, Inc. | 2000-05-11 | 42 | 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