510(k) · Cleared
ClearedXylos Xcell Antimicrobial 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 Mar 7, 2003 as substantially equivalent to K990530 (The Kendall Company, L.P., 2000) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.
- Decided
- Mar 7, 2003
- Review
- 88 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K970566 (1997). 7 ancestors in all, the oldest K895993 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 1 generation backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- This deviceK024054 Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
- Descendant · cites it directly · 3 of its ownK051647 Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK251582 Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK081274 Sureskin Silver BandagesEuromed, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK261646 Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc. · 2005 · cites it directly3descendants
- K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006 · cites it directly2descendants
- K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026 · 2 generations on1descendant
- K081274Sureskin Silver BandagesEuromed, Inc. · 2008 · 2 generations on1descendant
- K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −1 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| 0 (this device) | K024054 | Xylos Xcell Antimicrobial Dressing | Xylos Corporation | 2003 | — |
| +1 | K051647 | Fortaderm Antimicrobial Wound Dressing | Organogenesis, Inc. | 2005 | — |
| +1 | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| +2 | K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
| +2 | K081274 | Sureskin Silver Bandages | Euromed, Inc. | 2008 | — |
| +3 | K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 2 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990530 | Kerlix MD Antimicrobial Gauze DressingSummary page 1…Product CodelClassification Number: FRO Regulatory Class: Unclassified PREDICATE DEVICES: Kendall Kerlix Antimicrobial Gauze K990530 NAD ConvaTec Aquacel Ag Absorbent Antimicrobial Wound Dressing KO13814 FRO Maersk Medical Arglaes AB Antimicrobial Barr… | 2000 |
| * | K013814 | Absorbent Antimicrobial Wound Dressing | 2002 |
| * | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingSummary page 1…icrobial Gauze K990530 NAD ConvaTec Aquacel Ag Absorbent Antimicrobial Wound Dressing KO13814 FRO Maersk Medical Arglaes AB Antimicrobial Barrier Film Dressing K990810 MGP XYLOSTMXCellB Wound Dressing K974251 MGQ XYLOSTMXCellB Wound Dressing KO11379 Exempt NAE STATEMENT OF SUBSTANTIAL… | 1999 |
| * | K974251 | X-Cell Wound DressingSummary page 1…el Ag Absorbent Antimicrobial Wound Dressing KO13814 FRO Maersk Medical Arglaes AB Antimicrobial Barrier Film Dressing K990810 MGP XYLOSTMXCellB Wound Dressing K974251 MGQ XYLOSTMXCellB Wound Dressing KO11379 Exempt NAE STATEMENT OF SUBSTANTIAL EQUIVALENCE: XYLOSTMXCellB Antimicrobial… | 1998 |
| Kept off the family tree | K011379 | XYLOSTMXCellB Wound Dressing Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree |
What descends from it? (7)
3 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K051647 (Organogenesis, Inc., 2005) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K990530.
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?
The XCellB Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCellB Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the…
Read the full statement (179 words)
The XCellB Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCellB Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the supervision of a health care professional, the XCell@Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.
The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024054: Xylos Xcell Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024054
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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