510(k) · Cleared
ClearedInvia Motion Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 1, 2012 as substantially equivalent to K080357 (Medela AG, 2008) and 2 other predicates after a 292-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Oct 1, 2012
- Review
- 292 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945062 (1995). 20 ancestors in all, the oldest K933902 (1994). 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 2 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- This deviceK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- Descendant · cites it directly · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- Descendant · cites it directly · 4 of its ownK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · cites it directly8descendants
- K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014 · cites it directly5descendants
- K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG · 2016 · cites it directly4descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −2 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −1 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| 0 (this device) | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| +1 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | 1 |
| +1 | K141926 | Invia Endure Negative Pressure Wound Therapy System | Medela AG | 2014 | — |
| +1 | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120… | Medela AG | 2016 | 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 | — |
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 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K080357 | Medela Invia Wound TherapySummary page 1…E: Invia Motion COMMON/USUAL NAME: Negative Pressure Wound Therapy System CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Medela Invia Wound Therapy K083375 Smith and Nephew Renasys Go K093526 KCI USA, Inc. V.A.C.Via Negative Pressure Wound Therapy… | 2008 |
| * | K083375 | Renasys GO Negative Pressure Wound TherapySummary page 1…Negative Pressure Wound Therapy System CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Medela Invia Wound Therapy K083375 Smith and Nephew Renasys Go K093526 KCI USA, Inc. V.A.C.Via Negative Pressure Wound Therapy System… | 2009 |
| * | K093526 | V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Summary page 1…m CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Medela Invia Wound Therapy K083375 Smith and Nephew Renasys Go K093526 KCI USA, Inc. V.A.C.Via Negative Pressure Wound Therapy System Mede… | 2010 |
What descends from it? (11)
See all 113 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 17 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 20 ancestors have a recall of any class.
- Of its descendants, K170088 (Medela AG, 2017) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K080357.
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. 2012, 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 portable MedelaO Invia Motion negative pressure wound therapy (NPWT) system isindicated to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. It is intended for the use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with chronic, acute, subacute, traumatic, dlehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropethic, pressure or venous insufficiency), flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113678: Invia Motion 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/K113678
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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