510(k) · Cleared
ClearedAVELLE Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec Limited · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 19, 2018 as substantially equivalent to K151436 (Smith & Nephew Medical, Ltd., 2016) after a 268-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Oct 19, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945062 (1995). 24 ancestors in all, the oldest K933902 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 2 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 1 generation backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- This deviceK180205 AVELLE Negative Pressure Wound Therapy SystemConvatec Limited · 2018
- Descendant · cites it directly · 1 of its ownK190028 UNO 30Genadyne Biotechnologies · 2020
- Descendant · cites it directly · 0 of its ownK253263 ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
- Descendant · 2 generations on · 0 of its ownK221891 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
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 backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 4 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 3 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 2 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 1 generation backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- This deviceK180205 AVELLE Negative Pressure Wound Therapy SystemConvatec Limited · 2018
Most influential descendants
Showing 3 of 3 · See all- K190028UNO 30Genadyne Biotechnologies · 2020 · cites it directly1descendant
- K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026 · cites it directly0descendants
- K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022 · 2 generations on0descendants
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 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −4 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −3 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −2 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −1 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| 0 (this device) | K180205 | AVELLE Negative Pressure Wound Therapy System | Convatec Limited | 2018 | — |
| +1 | K190028 | UNO 30 | Genadyne Biotechnologies | 2020 | — |
| +1 | K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | 2026 | — |
| +2 | K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K151436 | PICO Single Use Negative Pressure Wound Therapy SystemSummary page 4…Class II Product Code: OMP Predicate Device Information Predicate Device 510(k) number Clearance Date PICO Single Use K151436 01/28/2016 Negative Pressure Wound Therapy System Device Description: The Avelle Negative Pressure Wound The… | 2016 |
What descends from it? (3)
2 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 23 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 24 ancestors have a recall of any class.
- Of its descendants, K190028 (Genadyne Biotechnologies, 2020) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K151436.
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. 2018, 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 Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as:
• Chronic Wounds e.g. Leg ulcers
• Acute Wounds
• Subacute and dehisced wounds
• Traumatic wounds
• Flaps & Grafts
• Surgically closed incision sites
Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180205: AVELLE Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180205
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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