Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Angiometrx, 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) |
|---|---|---|---|---|---|
| K051042 | METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX301 | Angiometrx, Inc. | 2005-08-05 | 102 | 0 |
| K042685 | METRICATH SYSTEM | Angiometrx, Inc. | 2004-11-18 | 50 | 0 |
| K024000 | METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRI | Angiometrx, Inc. | 2003-06-26 | 204 | 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