EdgeFlow UW20— 510(k) K252237

Name: FDA 510(k) clearance K252237
Creator: U.S. Food and Drug Administration
Published: 2026-04-17

Substantially Equivalent

Edgecare, Inc.

FDA 510(k) clearance K252237 for EdgeFlow UW20, Substantially Equivalent on 2026-04-17. Applicant: Edgecare, Inc.. Device class: 2.

Summary

Edgecare's EdgeFlow UW20 is filed under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 892.1560. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Edgecare filed from Seoul, South Korea. The record shows 274 calendar days from receipt to decision (July 17, 2025 to April 17, 2026).

Clearance details

Applicant: Edgecare, Inc.
Product code: Product code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2025-07-17
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.