Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kinetix — 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) |
|---|---|---|---|---|---|
| K832401 | RESPIROMETER | Kinetix | 1984-04-30 | 285 | 0 |
| K840459 | IMPROVED MOUTHPIECE | Kinetix | 1984-02-17 | 15 | 0 |
| K833420 | KINETIX MOUTHPIECE | Kinetix | 1984-01-10 | 99 | 0 |
| K833012 | INSPIROMETER | Kinetix | 1983-11-08 | 63 | 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