Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Direct Solutions — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
39 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963909 | HEMOCUE GLUCOLIN | Direct Solutions | 1996-11-08 | 39 | 0 |
| K964052 | HEMOCUE HEMOTROL | Direct Solutions | 1996-11-06 | 37 | 0 |
| K964053 | HEMOCUE GLUCOTROL | Direct Solutions | 1996-11-01 | 32 | 0 |
| K963908 | HEMOCUE HEMOLIN | Direct Solutions | 1996-10-16 | 16 | 0 |
| K955340 | EUROTROL GAS - ISE CONTROL | Direct Solutions | 1995-12-26 | 36 | 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