FDA applicant
H&abyz Co., Ltd.
FDA records 5 decisions for H&abyz Co., Ltd. (Yongin-Si, KR) from 2020 to 2025: 5 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “H&Abyz”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided H&abyz Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like H&abyz 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