Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Media Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
132 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953422 | FOX FASTIDIOUS TEST PANELS | Micro-Media Systems, Inc. | 1995-10-07 | 92 | 0 |
| K945997 | MODIFIED FOX EXTRA GRAM POSITIVE | Micro-Media Systems, Inc. | 1995-02-16 | 132 | 0 |
| K823738 | GRAM NEGATIVE BACTERIAL IDENTIF- PANELS | Micro-Media Systems, Inc. | 1983-01-07 | 25 | 0 |
| K801547 | TEST PANEL FOR PRESUMP. ID/BACT. ORG | Micro-Media Systems, Inc. | 1980-09-09 | 64 | 0 |
| K791991 | STREP-SPEC | Micro-Media Systems, Inc. | 1979-11-13 | 41 | 0 |
| K770746 | PANEL, IDENTIFICATION, STREP, MICRO-ID | Micro-Media Systems, Inc. | 1977-06-23 | 62 | 0 |
| K770745 | PANEL, GNF, MICRO-ID | Micro-Media Systems, Inc. | 1977-06-23 | 62 | 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