510(k) · Cleared
ClearedX-Cell Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xylos Corporation · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jun 22, 1998 after a 221-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Jun 22, 1998
- Review
- 221 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 3 citing it directly.
- This deviceK974251 X-Cell Wound DressingXylos Corporation · 1998
- Descendant · cites it directly · 12 of its ownK023237 Xylos Surgical MeshXylos Corporation · 2003
- Descendant · 2 generations on · 11 of its ownK081882 Modification to Xylos Surgical MeshXylos Corporation · 2008
- Descendant · 2 generations on · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · cites it directly · 7 of its ownK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- Descendant · 3 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K023237Xylos Surgical MeshXylos Corporation · 2003 · cites it directly12descendants
- K081882Modification to Xylos Surgical MeshXylos Corporation · 2008 · 2 generations on11descendants
- K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · 2 generations on9descendants
- K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003 · cites it directly7descendants
- K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974251 | X-Cell Wound Dressing | Xylos Corporation | 1998 | — |
| +1 | K023237 | Xylos Surgical Mesh | Xylos Corporation | 2003 | — |
| +2 | K081882 | Modification to Xylos Surgical Mesh | Xylos Corporation | 2008 | — |
| +2 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +1 | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| +3 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | NU-GEL hydrogel wound dressing Named without a submission number | |
| * | — | Aquacel wound dressing Named without a submission number |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023237 (Xylos Corporation, 2003) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
X-Cell™ wound dressing may be used for the management of:
Partial to Full thickness wounds (arterial, venous, pressure and diabetic ulcers);
First und Second degree bums (severe sunbum, eic.);
Post-operative surgical wounds;
Donor sites;
Dermal Lesions (cuts, abrasions, exc,)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974251: X-Cell Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974251
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026