510(k) · Cleared
Recalled · Class II · 2018Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
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 Dec 1, 2016 as substantially equivalent to K113678 (Medela AG, 2012) and 1 other predicate after a 224-day review. Its family tree reaches back 8 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 1, 2016
- Review
- 224 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K945062 (1995). 22 ancestors in all, the oldest K933902 (1994). 4 later devices descend 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 backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 2 generations backK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- 1 generation backK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- This deviceK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016
- Descendant · cites it directly · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · 2 generations on · 0 of its ownK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK223388 Invia® Integrated DressingMedela AG · 2023
- Descendant · 2 generations on · 0 of its ownK214112 Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 2022
Most influential descendants
Showing 4 of 4 · See all- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · cites it directly3descendants
- K254019Wound Geni NPWT SystemBechtel Medical, Inc. · 2026 · 2 generations on0descendants
- K223388Invia® Integrated DressingMedela AG · 2023 · 2 generations on0descendants
- K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 2022 · 2 generations on0descendants
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 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −3 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −2 | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| −1 | K141926 | Invia Endure Negative Pressure Wound Therapy System | Medela AG | 2014 | — |
| 0 (this device) | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120… | Medela AG | 2016 | — |
| +1 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +2 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
| +2 | K223388 | Invia® Integrated Dressing | Medela AG | 2023 | — |
| +2 | K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Medela AG | 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 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K113678 | Invia Motion Negative Pressure Wound Therapy SystemSummary page 4…E: Invia Motion COMMON/USUAL NAME: Negative Pressure Wound Therapy System CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K113678 Invia Motion Negative Pressure Wound Therapy System K141926 Invia Endure Negative Pressure Wound Therapy System… | 2012 |
| * | K141926 | Invia Endure Negative Pressure Wound Therapy SystemSummary page 4…Therapy System CLASSIFICATION NAMES: 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K113678 Invia Motion Negative Pressure Wound Therapy System K141926 Invia Endure Negative Pressure Wound Therapy System Volume 1, Page 115… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy… | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2018 | Class II | Z-2528-2018 | Device Design | Device may display a battery missing error. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 9 of the 22 ancestors have a recall of any class.
- Of its descendants, K172145 (Medela AG, 2018) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K113678.
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. 2016, 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 Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates 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 exudate and infectious material.
The Invia Motion NPWT system is appropriate for use for the following indications:
— Acute or subacute wounds
— Chronic wounds
— Dehisced wounds
— Pressure ulcers
— Diabetic/Neuropathic ulcers
— Venous insufficiency ulcers
— Traumatic wounds
— 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/K161128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161128: Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161128
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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