Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andon Medical Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
267 daysmedian FDA review time
585 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123935 | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2013-04-12 | 113 | 0 |
| K120813 | BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2012-12-07 | 263 | 0 |
| K110017 | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | Andon Medical Co., Ltd. | 2012-01-18 | 380 | 0 |
| K112738 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | Andon Medical Co., Ltd. | 2011-09-30 | 10 | 0 |
| K102678 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE | Andon Medical Co., Ltd. | 2011-08-26 | 344 | 0 |
| K101307 | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | Andon Medical Co., Ltd. | 2011-08-09 | 456 | 0 |
| K093755 | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-6 | Andon Medical Co., Ltd. | 2011-07-15 | 585 | 0 |
| K102609 | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MON | Andon Medical Co., Ltd. | 2010-12-09 | 90 | 0 |
| K093262 | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUC | Andon Medical Co., Ltd. | 2010-07-13 | 267 | 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