510(k) · Cleared

Cleared

V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via Dressing (Containing V.a.C. Granufoam D

K093526510(k) TraditionalCleared Mar 10, 2010114-day reviewClass II21 CFR 878.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Mar 10, 2010 as substantially equivalent to K063692 (Kci USA, Inc., 2007) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1995. 17 later devices descend from it.

Decided: Mar 10, 2010
Review: 114 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K945062 (1995). 6 ancestors in all. 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
2 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
1 generation backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
This deviceK093526 V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
Descendant · cites it directly · 11 of its ownK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
Descendant · 2 generations on · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
Descendant · 2 generations on · 5 of its ownK141926 Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014
Descendant · 2 generations on · 4 of its ownK161128 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia…Medela AG · 2016 · Recalled
Descendant · cites it directly · 4 of its ownK132741 V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 2013

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2012high 3 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 17 · See all

K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012 · cites it directly11descendants
K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · 2 generations on8descendants
K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG · 2014 · 2 generations on5descendants
K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG · 2016 · 2 generations on4descendants
K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 2013 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
−3	K971548	Ambuvac	Kinetic Concepts, Inc.	1997	—
−2	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	2
−1	K063692	V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000	Kci USA, Inc.	2007	1
0 (this device)	K093526	V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C.…	Kci USA, Inc. (Kinetic Concepts, Inc.)	2010	—
+1	K113678	Invia Motion Negative Pressure Wound Therapy System	Medela AG	2012	—
+2	K170088	Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad…	Medela AG	2017	1
+2	K141926	Invia Endure Negative Pressure Wound Therapy System	Medela AG	2014	—
+2	K161128	Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120…	Medela AG	2016	1
+1	K132741	V.a.C. Via Negative Pressure Wound Therapy System	Kci USA, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	1	0
2016	1	0
2017	3	0
2018	3	0
2019	2	0
2022	2	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K093526, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K063692	V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 Summary page 1 …ative pressure wound therapy powered suction pump name't~ (and components) ,L~'a~l~' KCI ActiV.A.C.e Therapy System ma~reteThp~t510(k) Numbers: K063692 and K091585 desctipton Divlcd * Devce dsign The V.A.C.ViaTMNPWT System consists of the following compon…	Kci USA, Inc.	2007	1
*	K091585	Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100 Cleared while this submission was under review Summary page 1 …re wound therapy powered suction pump name't~ (and components) ,L~'a~l~' KCI ActiV.A.C.e Therapy System ma~reteThp~t510(k) Numbers: K063692 and K091585 desctipton Divlcd * Devce dsign The V.A.C.ViaTMNPWT System consists of the following components:…	Kci USA, Inc.	2009	—

Also cleared against K063692: 3 other devices →

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113678	Invia Motion Negative Pressure Wound Therapy System	Medela AG	2012	11
K132741	V.a.C. Via Negative Pressure Wound Therapy System	Kci USA, Inc.	2013	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 15 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
2 of the 6 ancestors have a recall of any class.
Of its descendants, K113678 (Medela AG, 2012) has gone furthest, with 11 descendants of its own.
3 other devices also cite its predicate K063692.

How does its category compare?

All OMP devices

OMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OMP

5in 2025

2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007high 292 (2012) · low 84 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OMP

2in 2024

2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OMP

140in 2025

2007high 3,664 (2020) · low 1 (2007)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 V.A.C.Via Tm Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended 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 indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093526 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093526: V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via Dressing (Containing V.a.C. Granufoam D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093526

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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