510(k) · Cleared
ClearedAvance Foam Dressing Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care Us, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Mar 26, 2015 as substantially equivalent to K122132 (Molnlycke Health Care, 2013) and 1 other predicate after a 260-day review. Its family tree reaches back 7 generations to 1995. 14 later devices descend from it.
- Decided
- Mar 26, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945062 (1995). 12 ancestors in all, the oldest K914604 (1992). 14 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 3 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK122132 Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad…Molnlycke Health Care · 2013
- This deviceK141847 Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015
- Descendant · cites it directly · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · 2 generations on · 2 of its ownK182409 Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019
- Descendant · cites it directly · 2 of its ownK151872 Avance Y-Connector SMolnlycke Health Care Us, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK191460 PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · cites it directly8descendants
- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · 2 generations on3descendants
- K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019 · 2 generations on2descendants
- K151872Avance Y-Connector SMolnlycke Health Care Us, LLC · 2015 · cites it directly2descendants
- K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −6 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −5 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −4 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −3 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −1 | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium… | Molnlycke Health Care | 2013 | — |
| 0 (this device) | K141847 | Avance Foam Dressing Kits | Molnlycke Health Care Us, LLC | 2015 | — |
| +1 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | 1 |
| +2 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +2 | K182409 | Applied Tissue Technologies PWD™ Platform Wound Dressing | Applied Tissue Technologies, LLC | 2019 | — |
| +1 | K151872 | Avance Y-Connector S | Molnlycke Health Care Us, LLC | 2015 | — |
| +3 | K191460 | PWD Platform Wound Dressing 3” x 5” Oblong | Applied Tissue Technologies, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Summary page 5…OMP Avance® Foam Dressing Kits including Foam, Transparent Film and Transfer Pad and Avance® Foam Dressing Kits including Foam, Film with Safetac® and Transfer Pad - K122132 Mepitel® — K984371 Mbolnlycke Health Care holds a current clearance for a group of Negative Pressure Wound Therapy dressing kit… | 2013 |
| * | K984371 | Mepitel Non Adherent Silicone DressingSummary page 5…Dressing Kits including Foam, Transparent Film and Transfer Pad and Avance® Foam Dressing Kits including Foam, Film with Safetac® and Transfer Pad - K122132 Mepitel® — K984371 Mbolnlycke Health Care holds a current clearance for a group of Negative Pressure Wound Therapy dressing kits known as Avance® F… | 1999 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze… | 2017 | 8 |
| K151872 | Avance Y-Connector S | 2015 | 2 |
| K161935 | Avance Foam Dressing Kit - XL | 2016 | 0 |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | 2016 | 0 |
| K152741 | Mepiseal Soft Silicone Sealant | 2016 | 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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K170088 (Medela AG, 2017) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K122132.
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. 2015, 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?
The Avance® NPWT system, with associated products are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
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/K141847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141847: Avance Foam Dressing Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141847
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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