FDA applicant
Picopack Co., Ltd.
FDA records 2 decisions for Picopack Co., Ltd. (Daejeon, KR) from 2023 to 2024: 2 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Picopack, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Picopack Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Picopack Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report