K251591 is an FDA 510(k) clearance for the Holter ECG and ABP system (HolterABP). This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 9, 2026, 262 days after receiving the submission on May 23, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K251591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2025 |
| Decision Date | February 09, 2026 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |