Xylos Corporation: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Xylos Corporation” (first 1998, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 6 | 6 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| OMR | Vessel Guard Or Cover | 1 | 1 |
Review panels
Most recent Xylos Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111584 | XYLOS MACRO-POROUS SURGICAL MESH | FTM | 2011-08-25 | 79 |
| K100984 | XYLOS VESSEL GUARD | OMR | 2010-07-07 | 90 |
| K090880 | XYLOS POROUS SURGICAL MESH | FTM | 2009-05-27 | 57 |
| K090778 | MTA PROTECTIVE SHEET | FTM | 2009-04-28 | 36 |
| K083823 | SECURIAN TISSUE REINFORCEMENT MATRIX | FTM | 2009-03-18 | 86 |
| K081882 | MODIFICATION TO XYLOS SURGICAL MESH | FTM | 2008-07-11 | 9 |
| K023237 | XYLOS SURGICAL MESH | FTM | 2003-03-18 | 172 |
| K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | MGQ | 2003-03-07 | 88 |
| K974251 | X-CELL WOUND DRESSING | MGQ | 1998-06-22 | 221 |
Recalls
openFDA lists no recalls under a recalling firm named Xylos Corporation.
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.
Device clinical trials
An industry sponsor named Xylos Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00446823: Effectiveness of XCell on Autolytic Debridement of Venous Ulcers (Completed, started 2002-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xylos Corporation?
FDA lists 9 510(k) clearances under the applicant name “Xylos Corporation” (first 1998, latest 2011), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xylos Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xylos Corporation is 86 days.
Which FDA product codes appear under Xylos Corporation?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 6); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 2); OMR (Vessel Guard Or Cover, 1).
Next steps
- See all 9 Xylos Corporation clearances with predicates and recalls
- Run predicate analysis for product code FTM, Xylos Corporation'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.