AccurECG Analysis System (v2.0)
FDA 510(k) K252361 · Accurkardia, Inc.
510(k) numberK252361
Submission
- Device name
- AccurECG Analysis System (v2.0)
- Applicant
- Accurkardia, Inc.
New York, NY, US - Received
- July 29, 2025
- Decision date
- December 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
| K232161 | DeepRhythm PlatformDPS · Traditional | Medicalgorithmics S.A. | 06/20/2024SE |
More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K223013 | AccurECG Analysis SystemDPS · Traditional | 06/23/2023SE |
Questions and answers
When was AccurECG Analysis System (v2.0) cleared by the FDA?
AccurECG Analysis System (v2.0) (K252361) received a 510(k) decision of Substantially Equivalent on December 22, 2025, 146 days after the submission was received.
What is the product code of K252361?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.