Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sioxmed, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
293 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 | 293 | 0 |
| K242406 | SiOxC Cream | Sioxmed, LLC | 2025-03-13 | 211 | 0 |
| K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024-07-05 | 25 | 0 |
| K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023-12-18 | 95 | 0 |
| K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022-11-18 | 119 | 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