DeepRhythm Platform
FDA 510(k) K232161 · Medicalgorithmics S.A.
510(k) numberK232161
Submission
- Device name
- DeepRhythm Platform
- Applicant
- Medicalgorithmics S.A.
Warsaw, PL - Received
- July 20, 2023
- Decision date
- June 20, 2024
- 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 |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| 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 |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253141 | DeepRhythmAIDQK · Traditional | 12/11/2025SE |
| K250932 | DeepRhythmAIDQK · Traditional | 05/27/2025SE |
| K241197 | DeepRhythmAIDQK · Traditional | 12/04/2024SE |
| K210822 | DeepRhythmAIDQK · Traditional | 07/27/2022SE |
| K210758 | Q PatchMWJ · Traditional | 06/02/2022SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | 04/09/2020SE |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation SystemDSI · Abbreviated | 07/11/2018SE |
| K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic SystemDSI · Special | 10/08/2015SE |
| K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | 02/21/2013SE |
| K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic SystemDSI · Abbreviated | 05/16/2012SE |
Questions and answers
When was DeepRhythm Platform cleared by the FDA?
DeepRhythm Platform (K232161) received a 510(k) decision of Substantially Equivalent on June 20, 2024, 336 days after the submission was received.
What is the product code of K232161?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.