Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smith River Biologicals — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
36 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923892 | SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA | Smith River Biologicals | 1993-06-21 | 321 | 0 |
| K841204 | MULTIPLE BIOCHEMICAL TEST | Smith River Biologicals | 1984-04-17 | 36 | 0 |
| K841209 | SELECTIVE AND DIFFERENTIAL | Smith River Biologicals | 1984-04-17 | 36 | 0 |
| K841206 | NON-SELECTIVE & DIFFERENTIAL | Smith River Biologicals | 1984-04-17 | 36 | 0 |
| K841207 | NON-SELECTIVE & NON-DIFFERENTIAL | Smith River Biologicals | 1984-04-17 | 36 | 0 |
| K841208 | PROPAGATING TRANSPORT | Smith River Biologicals | 1984-04-05 | 24 | 0 |
| K841211 | SELECTIVE BROTH | Smith River Biologicals | 1984-04-05 | 24 | 0 |
| K841213 | ANTIMICROBIAL SUSCEPT-CULTURE MEDIA | Smith River Biologicals | 1984-04-04 | 23 | 0 |
| K841210 | SELECTIVE & NON-DIFFERENTIAL | Smith River Biologicals | 1984-04-04 | 23 | 0 |
| K841203 | GENERAL NUTRIENT BROTH | Smith River Biologicals | 1984-04-04 | 23 | 0 |
| K841212 | SINGLE BIOCHEMICAL TEST | Smith River Biologicals | 1984-04-04 | 23 | 0 |
| K841205 | NON PROPAGATING TRANSPORT | Smith River Biologicals | 1984-04-04 | 23 | 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