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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261580

510(k) cleared

ZBPro Diagnostic (Version 2.0)

Zbeats, Inc. · Sep 11, 2026 · K261580 · In the directory

FDA cleared the ZBPro Diagnostic (Version 2.0) from Zbeats, Inc. on Sep 11, 2026 under K261580, a traditional 510(k). The device falls under product code MLO, Electrocardiograph, Ambulatory, With Analysis Algorithm, regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 13, 2026. The decision came 121 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zbeats, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261580?

K261580 is the FDA 510(k) for ZBPro Diagnostic (Version 2.0), submitted by Zbeats, Inc.. FDA's decision date was Sep 11, 2026, under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm).

Who makes the ZBPro Diagnostic (Version 2.0)?

Zbeats, Inc., based in Stony Brook, NY, is the applicant of record for K261580. The company is listed in the MedDevice Startups directory.

How long did the K261580 review take?

FDA received the submission on May 13, 2026 and issued its decision on Sep 11, 2026, 121 days later.

← All decisions in September 2026

Sources

In the startup directory

ZBeats

Cardiovascular · Stony Brook, NY