510(k) Report

FDA applicant

VPIX Medical, Inc.

Daejeon, KR4 decisions2024–20260 recalls

FDA records 4 decisions for VPIX Medical, Inc. (Daejeon, KR) from 2024 to 2026: 4 510(k) clearances. Most are in product codes GWG (Endoscope, Neurological) and OWN (Confocal Optical Imaging). Its devices cite 2 predicates, 0 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, neurology panel, where it files most

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

FDA decisions per year

1in 2024

2024: 12026 (partial year): 3
2024high 3 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

Planning a device like VPIX Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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