510(k) · Cleared
ClearedAvance Abdominal Dressing Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care Us, LLC · OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Cleared on Nov 17, 2016 as substantially equivalent to K130852 (Molnlycke Health Care, 2014) after a 126-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Nov 17, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- OXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945062 (1995). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 6 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 5 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 4 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK112784 Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011
- 1 generation backK130852 Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014
- This deviceK161939 Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC · 2016
- Descendant · cites it directly · 0 of its ownK182722 XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies · 2019
Most influential descendants
Showing 1 of 1 · See all- K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −6 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −5 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −4 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −2 | K112784 | Renasys AB Abominal Dressing Kit | Smith & Nephew, Inc. | 2011 | — |
| −1 | K130852 | Avance® Foam Abdominal Dressing Kit | Molnlycke Health Care | 2014 | — |
| 0 (this device) | K161939 | Avance Abdominal Dressing Kit | Molnlycke Health Care Us, LLC | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 OXJ? 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? (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 |
|---|---|---|---|
| * | K130852 | Avance® Foam Abdominal Dressing KitSummary page 4…ation Number: 21 CFR 878.3300 Product Code: OXJ, OMP Predicate Device Information: Avance Abdominal Dressing Kit (K130852) Reference Device Information: Avance Foam Dressing Kits (K141847) Reason for 510(k) Submission: This premarket notific… | 2014 |
| † | K141847 | Avance Foam Dressing Kits | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182722 | XLR8 Abdominal Wound Dressing Kit | 2019 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K182722 (Genadyne Biotechnologies, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130852.
How does its category compare?
All OXJ devicesOXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OXJ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OXJ
Too few OXJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OXJ
No recall names OXJ since 2007.
Adverse event reports per year · OXJ
1in 2017
MAUDE reports naming product code OXJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161939: Avance Abdominal Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161939
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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