K252839 is an FDA 510(k) clearance for the ZywieZ3 Sensor & Adhesive. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.
Submitted by Zywie, Inc. (Johns Creek, US). The FDA issued a Cleared decision on June 18, 2026 after a review of 286 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Zywie, Inc. devices
NCT07188129
Completed
Interventional
Industry-sponsored
Evaluation of a Test Algorithm for Use to Analyze ECG Data Collected From a Test Device of a 24-hour Simulated Use Period
Assessing Compatibility of the ZywieAI Algorithm to Analyze ECG Data Collected From the Zywiez3 Sensor and Adhesive Over a 24-hour Period
| Condition studied |
Atrial Fibrillation (AF); Tachycardia; Bradycardia; PVC - Premature Ventricular Contraction; Premature Atrial Contraction |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Christopher M Beausoleil, B.S. |
| Sponsor |
Zywie, Inc.
(industry)
|
Started 2025-01-20
→
Primary completion 2025-05-06
→
Completed 2025-06-11
Primary outcome
Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects
Study completed - no results published.
This trial concluded in 2025 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov