FDA applicant
Ecotron Co., Ltd.
FDA records 4 decisions for Ecotron Co., Ltd. (Seoul, KR) from 2015 to 2022: 4 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 4 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
How often FDA has decided Ecotron Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Ecotron Co., Ltd.’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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