Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotest Medical Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
151 daysmedian FDA review time
362 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK | Biotest Medical Corp. | 2015-05-19 | 362 | 0 |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MU | Biotest Medical Corp. | 2014-02-21 | 99 | 0 |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | Biotest Medical Corp. | 2013-06-28 | 221 | 0 |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMAR | Biotest Medical Corp. | 2013-05-02 | 255 | 0 |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | Biotest Medical Corp. | 2010-05-12 | 72 | 0 |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | Biotest Medical Corp. | 2010-04-08 | 27 | 0 |
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | Biotest Medical Corp. | 2010-03-02 | 85 | 0 |
| K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | Biotest Medical Corp. | 2009-11-16 | 151 | 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