Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baui Biotech Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
329 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242899 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2024-10-17 | 24 | 0 |
| K191353 | COMET Lumbar Interbody Fusion Cage | Baui Biotech Co., Ltd. | 2020-04-14 | 329 | 0 |
| K191494 | Facilis™ Spinal System | Baui Biotech Co., Ltd. | 2019-08-12 | 68 | 0 |
| K182416 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2019-06-11 | 280 | 0 |
| K161231 | Facilis™ Spinal System | Baui Biotech Co., Ltd. | 2017-01-23 | 266 | 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