510(k) · Cleared
ClearedInvia Endure 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 Dec 19, 2014 as substantially equivalent to K080357 (Medela AG, 2008) and 1 other predicate after a 156-day review. Its family tree reaches back 7 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 156 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945062 (1995). 21 ancestors in all, the oldest K933902 (1994). 5 later devices descend from it, 1 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 backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 1 generation backK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- This deviceK141926 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 · 3 generations on · 0 of its ownK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK223388 Invia® Integrated DressingMedela AG · 2023
- Descendant · 3 generations on · 0 of its ownK214112 Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 2022
Most influential descendants
Showing 5 of 5 · See all- 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
- K254019Wound Geni NPWT SystemBechtel Medical, Inc. · 2026 · 3 generations on0descendants
- K223388Invia® Integrated DressingMedela AG · 2023 · 3 generations on0descendants
- K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 2022 · 3 generations on0descendants
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 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −2 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −1 | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| 0 (this device) | 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 | — |
| +3 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
| +3 | K223388 | Invia® Integrated Dressing | Medela AG | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K080357 | Medela Invia Wound TherapySummary page 4…a Endure COMMON/USUAL NAME: Negative Pressure Wound Therapy System CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Medela Invia Wound Therapy K113678 Medela Invia Motion Negative Pressure Wound Therapy System (Primary predicate) === Page 5 ==… | 2008 |
| * | K113678 | Invia Motion Negative Pressure Wound Therapy SystemSummary page 4…e Pressure Wound Therapy System CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Medela Invia Wound Therapy K113678 Medela Invia Motion Negative Pressure Wound Therapy System (Primary predicate)… | 2012 |
| † | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)… | 2013 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days… | 2016 | 4 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 21 ancestors have a recall of any class.
- Of its descendants, K161128 (Medela AG, 2016) has gone furthest, with 4 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. 2014, 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 Medela Invia Endure Negative Pressure Wound Therapy (NPWT) system is indicated 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, dehisced wounds, partial-thickness burns, ulcers (such as diabetic, neuropethic, pressure or venous insufficiency), 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/K141926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141926: Invia Endure 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/K141926
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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