Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microtech Medical Systems, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
217 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935485 | FAS FASTIDIOUS MIC PANEL | Microtech Medical Systems, Inc. | 1995-02-16 | 458 | 0 |
| K901598 | FASTIDIOUS MIC PANEL | Microtech Medical Systems, Inc. | 1990-11-08 | 217 | 0 |
| K896332 | SUPPLEMENT TO ANAEROBIC MIC PANEL | Microtech Medical Systems, Inc. | 1990-02-05 | 95 | 0 |
| K884831 | ANAEROBIC MIC PANEL | Microtech Medical Systems, Inc. | 1989-03-27 | 129 | 0 |
| K863847 | MIC - CONCEPT(TM) RX-2 | Microtech Medical Systems, Inc. | 1986-12-18 | 79 | 0 |
| K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) | Microtech Medical Systems, Inc. | 1986-05-20 | 13 | 0 |
| K860208 | QUADRA-TITER I.D. | Microtech Medical Systems, Inc. | 1986-03-03 | 40 | 0 |
| K852613 | MIC-CONCEPT SYSTEM | Microtech Medical Systems, Inc. | 1985-09-20 | 93 | 0 |
| K853745 | MIC-CONCEPT VIEWBOX | Microtech Medical Systems, Inc. | 1985-09-19 | 10 | 0 |
| K850725 | QUADRA TITER MICRO PLATES | Microtech Medical Systems, Inc. | 1985-04-30 | 67 | 0 |
| K851019 | MIC-CONCEPT INOCULUM SEED TRAY | Microtech Medical Systems, Inc. | 1985-03-29 | 17 | 0 |
| K851020 | MIC-CONCEPT INOCULATOR | Microtech Medical Systems, Inc. | 1985-03-29 | 17 | 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