Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curemetrix, 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) |
|---|---|---|---|---|---|
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 | 127 | 0 |
| K250754 | cmAngio® (V1.6) | Curemetrix, Inc. | 2025-04-10 | 29 | 0 |
| K232367 | cmAngio® V1.0 | Curemetrix, Inc. | 2023-10-05 | 58 | 0 |
| K183285 | cmTriage | Curemetrix, Inc. | 2019-03-08 | 102 | 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