FDA applicant
Dio Medical Co., Ltd.
FDA records 13 decisions for Dio Medical Co., Ltd. (East Norriton, PA) from 2010 to 2023: 13 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Dio Medical Corporation”, “Dio Medical, Inc.”, “Dio Medical Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dio Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Dio Medical 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