510(k) Report

FDA applicant

Edgecare, Inc.

Seoul, KR3 decisions2024–20260 recalls

FDA records 3 decisions for Edgecare, Inc. (Seoul, KR) from 2024 to 2026: 3 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and MUI (Media, Coupling, Ultrasound). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Edgecare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 2
2024high 2 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Edgecare, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions
  • MUIMedia, Coupling, Ultrasound1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231677EdgeFlow UH10Edgecare, Inc. · 20241cites it

What has FDA decided for it lately?

  • K252337EdgeFlow Gel PadEdgecare, Inc. · 2026
  • K252237EdgeFlow UW20Edgecare, Inc. · 2026
  • K231677EdgeFlow UH10Edgecare, Inc. · 2024

All 3 as Edgecare, Inc. →