ZBPro Diagnostic (Version 2.0)
FDA 510(k) K261580 · Zbeats, Inc.
510(k) numberK261580
Submission
- Device name
- ZBPro Diagnostic (Version 2.0)
- Applicant
- Zbeats, Inc.
Stony Brook, NY, US - Received
- May 13, 2026
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code MLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241890 | Philips Holter Analysis SystemMLO · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/21/2025SE |
| K240794 | Frontier X PlusMLO · Traditional | Fourth Frontier Technologies Pvt, Ltd. | 11/08/2024SE |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional | VivaQuant, Inc. | 09/02/2020SE |
| K193177 | Cer-SMLO · Traditional | Cardiocalm | 08/26/2020SE |
| K182030 | Faros MobileMLO · Abbreviated | Bittium Biosignals , Ltd. | 11/08/2018SE |
| K140847 | Cardiospy ECG Holter SystemsMLO · Traditional | Labtech Kft. | 12/05/2014SE |
| K131897 | CV3000 Holter Analysis SystemMLO · Traditional | Vales & Hills Biomedical Tech. , Ltd. | 11/26/2013SE |
| K130660 | Audicor Cpam with SDB (Single Sensor)MLO · Traditional | Inovise Medical, Inc. | 10/11/2013SE |
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional | Inovise Medical, Inc. | 09/20/2012SE |
| K111487 | NH-301 Ambulatory ECG Analysis SoftwareMLO · Special | Norav Medical Corp. | 11/10/2011SE |
More from Norav Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243252 | ZBPro DiagnosticDPS · Traditional | 07/10/2025SE |
Questions and answers
When was ZBPro Diagnostic (Version 2.0) cleared by the FDA?
ZBPro Diagnostic (Version 2.0) (K261580) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 121 days after the submission was received.
What is the product code of K261580?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.