Anumana, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Anumana, Inc.” (first 2023, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 2 | 41 |
| 2024 | 0 | — |
| 2025 | 1 | 146 |
| 2026 | 3 | 136 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anumana, Inc. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 1 | 1 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 1 | 1 |
Review panels
- Cardiovascular (5)
- Radiology (1)
Most recent Anumana, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260300 | WatchMate Software | QIH | 2026-06-15 | 136 |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | SHP | 2026-04-07 | 130 |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | SAT | 2026-03-28 | 242 |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | 2025-07-28 | 146 |
| K233160 | NeuTrace EP Mapping System v.2.1 | DQK | 2023-11-25 | 59 |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | QYE | 2023-09-28 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Anumana, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Anumana, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Anumana, Inc.” (first 2023, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anumana, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anumana, Inc. is 133 days. Since 2017: 133 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anumana, Inc.?
The most frequent FDA product codes under this applicant name are QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software, 2); DQK (Computer, Diagnostic, Programmable, 1); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 6 Anumana, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QYE, Anumana, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.