Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dio Medical Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
162 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162849 | Huvex Interspinous Fixation System | Dio Medical Co., Ltd. | 2017-02-16 | 128 | 0 |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | Dio Medical Co., Ltd. | 2016-11-21 | 105 | 0 |
| K122872 | INTERVERTEBRAL BODY FUSION DEVICE | Dio Medical Co., Ltd. | 2013-02-28 | 162 | 0 |
| K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM | Dio Medical Co., Ltd. | 2012-10-31 | 127 | 0 |
| K113324 | REXIOUS HOOK FIXATION SYSTEMS | Dio Medical Co., Ltd. | 2012-03-28 | 139 | 0 |
| K111362 | REXIOUS SPINAL FIXATION SYSTEM | Dio Medical Co., Ltd. | 2011-07-21 | 66 | 0 |
| K100765 | FIXPINE II SYSTEM | Dio Medical Co., Ltd. | 2010-07-19 | 124 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda