Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mid Tech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
56 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810951 | REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. | Mid Tech, Inc. | 1981-04-23 | 16 | 0 |
| K791869 | GLUCOSE OXIDASE (FRINDER) KIT | Mid Tech, Inc. | 1979-10-01 | 11 | 0 |
| K791313 | ARS, CHEMISTRY | Mid Tech, Inc. | 1979-08-16 | 35 | 0 |
| K771033 | SMAC SYS., SUPPLEMENTAL PRODUCTS FOR | Mid Tech, Inc. | 1977-08-04 | 56 | 0 |
| K770508 | SMAC SYSTEM | Mid Tech, Inc. | 1977-05-09 | 53 | 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