510(k) · Cleared
Recalled · 2011Medela Invia Wound Therapy
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 Jul 24, 2008 as substantially equivalent to K061205 (Medela AG, 2006) and 1 other predicate after a 164-day review. Its family tree reaches back 3 generations to 1995. 75 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 2008
- Review
- 164 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945062 (1995). 9 ancestors in all, the oldest K933902 (1994). 75 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 1 generation backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- This deviceK080357 Medela Invia Wound TherapyMedela AG · 2008
- Descendant · cites it directly · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 3 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · 2 generations on · 15 of its ownK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · cites it directly56descendants
- K111170PICOSmith & Nephew, Inc. · 2011 · 2 generations on26descendants
- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 2 generations on25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 3 generations on23descendants
- K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −1 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| 0 (this device) | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | — |
| +1 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| +2 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +2 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +3 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| +2 | K091470 | Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 | Smith & Nephew, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 8 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K061205 | Medela Vario 8/18/CI Secretion & Surgical AspiratorSummary page 1…fied Class II, per 21 CFR 878.4780 Product Code: JCX 3 Name of the predicate Device(s) * Medela® Vario 8/18/ci Suction Pumps, by Medela AG K061205 * KCI V.A.C. Freedom, by KCI KINETIC CONCEPTS, INC. K03231 0 E_51 OkSummary Liberty_20080620.doc 2008-06-20… | 2006 |
| * | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. AtsSummary page 1…3 Name of the predicate Device(s) * Medela® Vario 8/18/ci Suction Pumps, by Medela AG K061205 * KCI V.A.C. Freedom, by KCI KINETIC CONCEPTS, INC. K03231 0 E_51 OkSummary Liberty_20080620.doc 2008-06-20 Section E -1 of 3… | 2003 |
What descends from it? (75)
See all 757 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083375 | Renasys GO Negative Pressure Wound Therapy | 2009 | 56 |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set… | 2015 | 12 |
| K113678 | Invia Motion Negative Pressure Wound Therapy System | 2012 | 11 |
| K100823 | Wound Pro Apex | 2011 | 10 |
| K141926 | Invia Endure Negative Pressure Wound Therapy System | 2014 | 5 |
| K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and… | 2012 | 4 |
| K150960 | WoundPro Negative Pressure Wound Therapy System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2011 | Not classified | Z-3172-2011 | Error in labeling | Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K083375 (Smith & Nephew, Inc., 2009) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K061205.
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. 2008, 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 Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080357 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080357: Medela Invia Wound Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080357
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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