510(k) · Cleared

Cleared

V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U

K100657510(k) TraditionalCleared Sep 17, 2010193-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 Sep 17, 2010 as substantially equivalent to K021501 (Kinetic Concepts, Inc., 2002) and 1 other predicate after a 193-day review. Its family tree reaches back 3 generations to 1995. 19 later devices descend from it.

Decided: Sep 17, 2010
Review: 193 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K945062 (1995). 5 ancestors in all. 19 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
1 generation backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
This deviceK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
Descendant · cites it directly · 10 of its ownK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
Descendant · 2 generations on · 9 of its ownK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
Descendant · 2 generations on · 8 of its ownK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
Descendant · 3 generations on · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
Descendant · 3 generations on · 5 of its ownK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011high 3 (2016) · low 0 (2012)2026

Most influential descendants

Showing 5 of 19 · See all

K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015 · cites it directly10descendants
K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc. · 2016 · 2 generations on9descendants
K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016 · 2 generations on8descendants
K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc. · 2018 · 3 generations on7descendants
K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc. · 2018 · 3 generations on5descendants

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	K021501	V.a.C. Instillamat (Vacuum Assisted Closure Instillamat	Kinetic Concepts, Inc.	2002	—
0 (this device)	K100657	V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy…	Kci USA, Inc. (Kinetic Concepts, Inc.)	2010	—
+1	K141017	Prevena Incision Management System with Peel & Dressing, Prevena Incision…	Kci USA, Inc. (Kinetic Concepts, Inc.)	2015	—
+2	K153199	Prevena Plus Incision Management System Kit with Peel & Place Dressing…	Kci USA, Inc.	2016	—
+2	K161897	PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE…	Kci USA, Inc. (Kinetic Concepts, Inc.)	2016	—
+3	K173426	PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management…	Kci USA, Inc.	2018	—
+3	K180855	Prevena Plus Incision Management System, Prevena Plus Duo Incision Management…	Kci USA, Inc.	2018	—

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
2011	1	0
2015	1	0
2016	3	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	3	0
2022	1	0
2023	2	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K100657, 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
*	K021501	V.a.C. Instillamat (Vacuum Assisted Closure Instillamat	Kinetic Concepts, Inc.	2002	—
*	K091585	Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100 Summary page 1 …ative Pressure Wound Therapy Powered Suction Pump name (and components) Legally marketed devie~)to wich V.A.C. Instillamnat Device (KO21501 and K091 585) equivalence is claimed A negative pressure wound therapy system with an instillation feature Device descr…	Kci USA, Inc.	2009	—

Also cleared against K021501: 3 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K141017	Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…	Kci USA, Inc. (Kinetic Concepts, Inc.)	2015	10
K162790	V.A.C.ULTA Negative Pressure Wound Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2017	3
K103156	V.a.C. Veraflo Cleanse Dressing System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2011	3

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 2 companies; a new generation was cleared every 5.5 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K141017 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2015) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K021501.

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.U/ta Negat/ve Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation 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…

Read the full statement (138 words)

The V.A. C.U/ta Negat/ve Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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 exudt and infetius materia

The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A. C.U/ta Tm Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as dia6etic, pressure and venous insufficiency), flaps and grafts.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100657 · printed Nov 3, 2026

Cite this page

510(k) Report. “K100657: V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100657

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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