Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sporicidin Intl. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
587 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003087 | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLU | Sporicidin Intl. | 2000-11-07 | 41 | 0 |
| K983194 | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) | Sporicidin Intl. | 1999-03-05 | 175 | 0 |
| K926013 | SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI | Sporicidin Intl. | 1993-02-12 | 80 | 0 |
| K922262 | SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT | Sporicidin Intl. | 1992-09-15 | 126 | 0 |
| K904581 | SPORICIDIN BRAND DISINFECTANT SOLUTION | Sporicidin Intl. | 1992-05-18 | 587 | 0 |
| K904580 | SPORICIDIN BRAND DISINFECTANT SPRAY | Sporicidin Intl. | 1992-05-18 | 587 | 0 |
| K904579 | SPORICIDIN BRAND DISINFECTANT TOWELETTES | Sporicidin Intl. | 1992-05-18 | 587 | 0 |
| K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION | Sporicidin Intl. | 1983-06-30 | 114 | 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