Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M.K. Meditech Co. , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
74 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050131 | INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE | M.K. Meditech Co. , Ltd. | 2005-04-05 | 74 | 0 |
| K034031 | 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE | M.K. Meditech Co. , Ltd. | 2004-01-21 | 23 | 0 |
| K031594 | BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY | M.K. Meditech Co. , Ltd. | 2003-06-06 | 16 | 0 |
| K022806 | DUOPRO SAFETY SYRINGE (DUOPROSS) | M.K. Meditech Co. , Ltd. | 2002-09-19 | 27 | 0 |
| K020623 | DUOPRO SAFETY SYRINGE (DUOPROSS) | M.K. Meditech Co. , Ltd. | 2002-05-02 | 65 | 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