Predicate Research Report · generated 2026-08-24 · Print / save as PDF · Save to account
Diversatek Healthcare · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230056 | MiVu™ Esophageal Endo Cap | Diversatek Healthcare | 2023-04-25 | 106 | 0 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bott | Diversatek Healthcare | 2022-11-08 | 60 | 0 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (H | Diversatek Healthcare | 2019-10-03 | 241 | 1 |
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