Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bk Meditech, Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
261 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | 2020-08-11 | 119 | 0 |
| K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018-12-10 | 35 | 0 |
| K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018-03-15 | 167 | 0 |
| K140577 | INNESIS PEEK TL CAGE | Bk Meditech, Co., Ltd. | 2014-10-01 | 209 | 0 |
| K132483 | INNESIS PEEK CERVICAL CAGE | Bk Meditech, Co., Ltd. | 2014-04-02 | 237 | 0 |
| K120464 | INNESIS PEEK CAGE | Bk Meditech, Co., Ltd. | 2013-01-18 | 338 | 0 |
| K110426 | DYNA-EXTOR II | Bk Meditech, Co., Ltd. | 2011-11-02 | 261 | 0 |
| K090424 | DVX SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2009-05-14 | 84 | 0 |
| K080876 | DVX SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2008-06-04 | 65 | 0 |
| K072436 | MEGA SPINE SYSTEM | Bk Meditech, Co., Ltd. | 2007-11-01 | 63 | 0 |
| K061599 | PIN SCREW | Bk Meditech, Co., Ltd. | 2006-07-26 | 48 | 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