510(k) · Cleared
Recalled · Class II · 2019Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
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 Apr 6, 2017 as substantially equivalent to K151261 (Medela AG, 2015) and 3 other predicates after an 86-day review. Its family tree reaches back 8 generations to 1995. 8 later devices descend from it. It has been recalled once.
- Decided
- Apr 6, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K945062 (1995). 31 ancestors in all, the oldest K914604 (1992). 8 later devices descend from it, 3 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 backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 2 generations backK122132 Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad…Molnlycke Health Care · 2013
- 1 generation backK141847 Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015
- This deviceK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017
- Descendant · cites it directly · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · cites it directly · 2 of its ownK182409 Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK191460 PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · cites it directly3descendants
- K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019 · cites it directly2descendants
- K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019 · 2 generations on1descendant
- K254019Wound Geni NPWT SystemBechtel Medical, Inc. · 2026 · 2 generations on0descendants
- K223388Invia® Integrated DressingMedela AG · 2023 · 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 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −2 | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium… | Molnlycke Health Care | 2013 | — |
| −1 | K141847 | Avance Foam Dressing Kits | Molnlycke Health Care Us, LLC | 2015 | — |
| 0 (this device) | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | — |
| +1 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +1 | K182409 | Applied Tissue Technologies PWD™ Platform Wound Dressing | Applied Tissue Technologies, LLC | 2019 | — |
| +2 | K191460 | PWD Platform Wound Dressing 3” x 5” Oblong | Applied Tissue Technologies, LLC | 2019 | — |
| +2 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
| +2 | K223388 | Invia® Integrated Dressing | Medela AG | 2023 | — |
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 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Summary page 6…FOAM DRESSING KITS WITH FITPAD 1. PRIMARY PREDICATE DEVICE DEVICE TRADE NAME: Invia Foam Dressing Kit APPLICANT: Medela AG 510(K) NO.: K151261 2. PREDICATE DEVICE DEVICE TRADE NAME: Avance® Foam Dressing Kits APPLICANT: Molnlycke Health Care US LLC 51… | 2015 |
| * | K141847 | Avance Foam Dressing KitsSummary page 6…K151261 2. PREDICATE DEVICE DEVICE TRADE NAME: Avance® Foam Dressing Kits APPLICANT: Molnlycke Health Care US LLC 510(K) NO.: K141847 INVIA GAUZE DRESSING KITS WITH FITPAD 1. PRIMARY PREDICATE DEVICE DEVICE TRADE NAME: Invia Motion APPLICANT:… | 2015 |
| * | K113678 | Invia Motion Negative Pressure Wound Therapy SystemSummary page 6…47 INVIA GAUZE DRESSING KITS WITH FITPAD 1. PRIMARY PREDICATE DEVICE DEVICE TRADE NAME: Invia Motion APPLICANT: Medela AG 510(K) NO.: K113678 2. PREDICATE DEVICE DEVICE TRADE NAME: KCI NPWT Gauze Dressing APPLICANT: KCI USA, Inc. (Kinetic Concepts, I… | 2012 |
| * | K123507 | Kci NPWT Gauze DressingSummary page 6…K113678 2. PREDICATE DEVICE DEVICE TRADE NAME: KCI NPWT Gauze Dressing APPLICANT: KCI USA, Inc. (Kinetic Concepts, Inc.) 510(K) NO.: K123507 K170088 Page 3/5 DEVICE DESCRIPTION I… | 2013 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2019 | Class II | Z-0773-2020 | Packaging | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 11 of the 31 ancestors have a recall of any class.
- Of its descendants, K172145 (Medela AG, 2018) has gone furthest, with 3 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. 2017, 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 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 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…
Read the full statement (243 words)
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 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 Foam Dressing Kit with FitPad is appropriate for use on the following wounds:
– Acute or sub-acute wounds
– Chronic wounds
– Dehisced wounds
– Pressure ulcers
– Diabetic/neuropathic ulcers
– Venous insufficiency ulcers
– Traumatic wounds
– Partial thickness burns
– Flaps and grafts
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 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.
Invia Gauze Dressing Kit with FitPad is appropriate for use on the following wounds:
– Acute or sub-acute wounds
– Chronic wounds
– Dehisced wounds
– Pressure ulcers
– Diabetic/neuropathic ulcers
– Venous insufficiency ulcers
– Traumatic wounds
– Partial thickness burns
– Flaps and Grafts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170088
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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