510(k) · Cleared
ClearedInvia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
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 May 9, 2018 as substantially equivalent to K161128 (Medela AG, 2016) and 3 other predicates after a 296-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- May 9, 2018
- Review
- 296 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K945062 (1995). 37 ancestors in all, the oldest K914604 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- 2 generations backK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- 1 generation backK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · Recalled
- This deviceK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · cites it directly · 0 of its ownK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK223388 Invia® Integrated DressingMedela AG · 2023
- Descendant · cites it directly · 0 of its ownK214112 Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG · 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 backK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- 2 generations backK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
- 1 generation backK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · Recalled
- This deviceK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
Most influential descendants
Showing 3 of 3 · See allView 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 | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| −2 | 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 |
| 0 (this device) | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +1 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
| +1 | K223388 | Invia® Integrated Dressing | Medela AG | 2023 | — |
| +1 | 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 |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Summary page 8…Medela AG K172145 PREDICATE DEVICE(S): Invia Motion Negative Pressure Wound Therapy System (all models) (K161128) Invia Liberty Negative Pressure Wound Therapy System (K142626) Invia Foam Dressing Kits with FitPad (K170088) ActiV.A.C. Therapy… | 2016 |
| * | K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Summary page 8…K172145 PREDICATE DEVICE(S): Invia Motion Negative Pressure Wound Therapy System (all models) (K161128) Invia Liberty Negative Pressure Wound Therapy System (K142626) Invia Foam Dressing Kits with FitPad (K170088) ActiV.A.C. Therapy Unit (K120033) VA.C Therapy System using Granufoam Dressing (K… | 2015 |
| * | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Summary page 8…Motion Negative Pressure Wound Therapy System (all models) (K161128) Invia Liberty Negative Pressure Wound Therapy System (K142626) Invia Foam Dressing Kits with FitPad (K170088) ActiV.A.C. Therapy Unit (K120033) VA.C Therapy System using Granufoam Dressing (K120033) DEVICE DESCRIPTION: The labeling of t… | 2017 |
| * | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Summary page 8…rapy System (all models) (K161128) Invia Liberty Negative Pressure Wound Therapy System (K142626) Invia Foam Dressing Kits with FitPad (K170088) ActiV.A.C. Therapy Unit (K120033) VA.C Therapy System using Granufoam Dressing (K120033) DEVICE DESCRIPTION: The labeling of the Invia Motion Negative Pressure… | 2012 |
What descends from it? (3)
3 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 4 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 37 ancestors have a recall of any class.
- Of its descendants, K254019 (Bechtel Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
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 Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds 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.…
Read the full statement (682 words)
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a
suction device (Negative Pressure Wound Therapy) as when used on open wounds 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.
When used on closed surgical incisions, the Invia Motion NPWT system is also intended to manage the environment of
surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and
removing exudate via the application of Negative Pressure Wound Therapy.
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
– Closed surgical incisions
The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a
suction device (Negative Pressure Wound Therapy) as when used on open wounds 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.
When used on closed surgical incisions, the Invia Liberty NPWT system is also intended to manage the environment of
surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and
removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Liberty 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
– Closed surgical incisions
The Invia Foam Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure
Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure
Wound Therapy) as when used on open wounds 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.
When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is also intended to manage the
environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed
environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Foam Dressing Kit with FitPad 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
– Closed surgical incisions
The Invia Gauze Dressing Kit with FitPad in conjunction with the Invia Motion and Invia Liberty Negative Pressure
Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure
Wound Therapy) as when used on open wounds 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.
When used on closed surgical incisions, the Invia Gauze Dressing Kit with FitPad is also intended to manage the
environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed
environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Gauze Dressing Kit with FitPad 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
– Closed surgical incisions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172145: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172145
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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