Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bestgen Biotech Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
509 daysmedian FDA review time
694 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103230 | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTR | Bestgen Biotech Corp. | 2012-04-24 | 540 | 0 |
| K103116 | AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTE | Bestgen Biotech Corp. | 2012-03-13 | 509 | 0 |
| K103044 | AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR G | Bestgen Biotech Corp. | 2012-02-10 | 484 | 0 |
| K100437 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJO | Bestgen Biotech Corp. | 2012-01-12 | 694 | 0 |
| K090389 | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM | Bestgen Biotech Corp. | 2009-07-14 | 147 | 0 |
| K072274 | MAJOR III BLOOD GLUCOSE MONITORING SYSTEM | Bestgen Biotech Corp. | 2008-02-29 | 198 | 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