Sioxmed, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sioxmed, LLC” (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 119 days, against 220 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 119 |
| 2023 | 1 | 95 |
| 2024 | 1 | 25 |
| 2025 | 1 | 211 |
| 2026 | 1 | 293 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sioxmed, LLC took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSZ | Absorbable Synthetic Wound Dressing | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
Review panels
Most recent Sioxmed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250890 | SBC1 Cream | FRO | 2026-01-12 | 293 |
| K242406 | SiOxC Cream | FRO | 2025-03-13 | 211 |
| K241660 | SiOxD® Wound Matrix | QSZ | 2024-07-05 | 25 |
| K232847 | SiOxD Wound Matrix | QSZ | 2023-12-18 | 95 |
| K222189 | SiOxD Wound Matrix | QSZ | 2022-11-18 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Sioxmed, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sioxmed, LLC?
FDA lists 5 510(k) clearances under the applicant name “Sioxmed, LLC” (first 2022, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sioxmed, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sioxmed, LLC is 119 days. Since 2017: 119 days, versus 220 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sioxmed, LLC?
The most frequent FDA product codes under this applicant name are QSZ (Absorbable Synthetic Wound Dressing, 3); FRO (Dressing, Wound, Drug, 2).
Next steps
- See all 5 Sioxmed, LLC clearances with predicates and recalls
- Run predicate analysis for product code QSZ, Sioxmed, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.