510(k) · Cleared
ClearedXLR8 Abdominal Wound Dressing Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genadyne Biotechnologies · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 27, 2019 as substantially equivalent to K161939 (Molnlycke Health Care Us, LLC, 2016) after a 364-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Sep 27, 2019
- Review
- 364 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945062 (1995). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK112784 Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011
- 2 generations backK130852 Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014
- 1 generation backK161939 Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC · 2016
- This deviceK182722 XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies · 2019
Show all 9 generations
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 7 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 6 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 5 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 4 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 3 generations backK112784 Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011
- 2 generations backK130852 Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014
- 1 generation backK161939 Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC · 2016
- This deviceK182722 XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −8 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −7 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −6 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −5 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −4 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −3 | K112784 | Renasys AB Abominal Dressing Kit | Smith & Nephew, Inc. | 2011 | — |
| −2 | K130852 | Avance® Foam Abdominal Dressing Kit | Molnlycke Health Care | 2014 | — |
| −1 | K161939 | Avance Abdominal Dressing Kit | Molnlycke Health Care Us, LLC | 2016 | — |
| 0 (this device) | K182722 | XLR8 Abdominal Wound Dressing Kit | Genadyne Biotechnologies | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 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 OMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K161939 | Avance Abdominal Dressing KitSummary page 4…ice Class: Class II Regulation Number: 21 CFR 878.4780 Classification Product Code: OMP Subsequent Product Code: FTL Predicate Device: Avance Abdominal Dressing Kit, K161939 Device Description XLR8 Abdominal Wound dressing is a negative pressure wound therapy device intended to provide negative pre… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 18 ancestors have a recall of any class.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, 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 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
XLR8 Abdominal Wound Dressing Kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound dressing foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required.
It is intended for use in acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182722: XLR8 Abdominal Wound Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182722
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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