Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mattioli Engineering Corp. — 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) |
|---|---|---|---|---|---|
| K100053 | MATTIOLI PULSE TWO/THREE PLUS FAMILY | Mattioli Engineering Corp. | 2010-03-10 | 61 | 0 |
| K042590 | TRANSDERM IONTO SYSTEM, MK 2 | Mattioli Engineering Corp. | 2004-10-14 | 21 | 0 |
| K032968 | TRSANSDERM IONTO SYSTEM | Mattioli Engineering Corp. | 2003-12-02 | 70 | 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