Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Galvanize Therapeutics, Inc. · 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) |
|---|---|---|---|---|---|
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® | Galvanize Therapeutics, Inc. | 2026-05-07 | 157 | 0 |
| K233884 | INUMI™ Flex Needle | Galvanize Therapeutics, Inc. | 2024-05-22 | 166 | 0 |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Ali | Galvanize Therapeutics, Inc. | 2022-06-17 | 281 | 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