510(k) · Cleared
ClearedAvance Solo Negative Pressure Wound Therapy (NPWT) System
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 Jul 1, 2021 as substantially equivalent to K163387 (Smith & Nephew Medical Limited, 2017) and 1 other predicate after a 227-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jul 1, 2021
- Review
- 227 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945062 (1995). 26 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations between
- 3 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 2 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 1 generation backK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- This deviceK203369 Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC · 2021
Show all 10 generations
- Root · 10 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 9 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 8 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 7 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 6 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 5 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 4 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 3 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 2 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 1 generation backK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- This deviceK203369 Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −9 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −8 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −7 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −6 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −5 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −4 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −3 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −2 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −1 | K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017 | — |
| 0 (this device) | K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K163387 | PICO Single Use Negative Pressure Wound Therapy SystemSummary page 4…Regulation Number: 21 CFR 878.4780 Product Code: OMP Predicate Device Name(s): PICO Single Use NPWT System (K163387) ActiVAC Therapy Unit (K120033) Description of Device: Avance Solo Negative Pressure Woun… | 2017 |
| * | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Summary page 4…: OMP Predicate Device Name(s): PICO Single Use NPWT System (K163387) ActiVAC Therapy Unit (K120033) Description of Device: Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Cani… | 2012 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K163387.
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. 2021, 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 Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
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/K203369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203369: Avance Solo Negative Pressure Wound Therapy (NPWT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203369
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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