Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anumana, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
242 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260300 | WatchMate Software | Anumana, Inc. | 2026-06-15 | 136 | 0 |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | 2026-04-07 | 130 | 0 |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026-03-28 | 242 | 0 |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025-07-28 | 146 | 0 |
| K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | 2023-11-25 | 59 | 0 |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023-09-28 | 23 | 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