Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blue Ridge Media Co. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
21 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820846 | ANTIMICROBIAL SUSCEP. TEST, MUELLER | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820842 | CULTURE MEDIA, NON-SELECTIVE/DIFFER | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820847 | ISOLATION OF PATHOGENIC NEISSERIA | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820843 | CULTURE MEDIA SELECTIVE BROTH | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820844 | CULTURE MEDIA, SELECTIVE & DIFFERENTIAL | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820849 | BLUE RIDGE RABBIT BLOOD | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820848 | BLUE RIDGE SHEEP BLOOD | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820845 | DULTURE MEDIA, SELECTIVE & NON-DIFFER | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820841 | CULTURE MEDIA, MULTIPLE BIOCHEMICAL | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820839 | CULTURE MEDIA, SINGLE BIOCHEM. TEST | Blue Ridge Media Co. | 1982-04-16 | 21 | 0 |
| K820840 | CULTURE MEDIA, GENERAL NUTRIENT BROTH | Blue Ridge Media Co. | 1982-04-16 | 21 | 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