Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bm Korea Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
260 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | Bm Korea Co., Ltd. | 2015-01-16 | 88 | 0 |
| K122518 | SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERV | Bm Korea Co., Ltd. | 2013-02-15 | 182 | 0 |
| K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYST | Bm Korea Co., Ltd. | 2012-05-09 | 93 | 0 |
| K111820 | SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLI | Bm Korea Co., Ltd. | 2012-03-14 | 260 | 0 |
| K111593 | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | Bm Korea Co., Ltd. | 2011-11-18 | 164 | 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