FDA applicant
Jpi Healthcare Co, Ltd.
FDA records 10 decisions for Jpi Healthcare Co, Ltd. (Seoul, KR) from 1995 to 2026: 10 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Jpi Healthcare, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jpi Healthcare 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 2007.
Planning a device like Jpi Healthcare 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