510(k) · Cleared

Cleared

Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit

K120033510(k) TraditionalCleared May 31, 2012148-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. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on May 31, 2012 as substantially equivalent to K100821 (Kci USA, Inc., 2010) after a 148-day review. Its family tree reaches back 1 generation to 2010. 25 later devices descend from it.

Decided: May 31, 2012
Review: 148 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K100821 (2010). 25 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
This deviceK120033 Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit…Kci USA, Inc. · 2012
Descendant · cites it directly · 9 of its ownK133276 V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round…Kci USA, Inc. · 2013
Descendant · 2 generations on · 5 of its ownK181505 V.A.C. DERMATAC DrapeKci USA, Inc. · 2019
Descendant · cites it directly · 4 of its ownK183543 ACTIV.A.C. Therapy UnitKci USA, Inc. · 2019 · Recalled
Descendant · cites it directly · 4 of its ownK132741 V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK201571 ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2013high 4 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 25 · See all

K133276V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…Kci USA, Inc. · 2013 · cites it directly9descendants
K181505V.A.C. DERMATAC DrapeKci USA, Inc. · 2019 · 2 generations on5descendants
K183543ACTIV.A.C. Therapy UnitKci USA, Inc. · 2019 · cites it directly4descendants
K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 2013 · cites it directly4descendants
K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K100821	Prevena Incision Management System	Kci USA, Inc.	2010	8
0 (this device)	K120033	Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac…	Kci USA, Inc.	2012	—
+1	K133276	V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing…	Kci USA, Inc.	2013	—
+2	K181505	V.A.C. DERMATAC Drape	Kci USA, Inc.	2019	—
+1	K183543	ACTIV.A.C. Therapy Unit	Kci USA, Inc.	2019	1
+1	K132741	V.a.C. Via Negative Pressure Wound Therapy System	Kci USA, Inc.	2013	—
+2	K201571	ACTIV.A.C. Negative Pressure Wound Therapy System	Kci USA, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2016	1	0
2017	2	0
2018	2	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	4	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K120033, 2010–2026Source: 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? (1)

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
*	K100821	Prevena Incision Management System Summary page 1 …ion panel General and Plastic Surgery Regulation 678.4780 Product Code(s) OMP Legally marketed Prevena Incision Management System (K1 00821) device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] Device description Negative pressure wound therapy system…	Kci USA, Inc.	2010	8

Also cleared against K100821: 5 other devices →

What descends from it? (25)

See all 25

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

Number	Device	Applicant	Decided	Descendants
K133276	V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…	Kci USA, Inc.	2013	9
K183543	ACTIV.A.C. Therapy Unit	Kci USA, Inc.	2019	4
K132741	V.a.C. Via Negative Pressure Wound Therapy System	Kci USA, Inc.	2013	4
K172145	Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…	Medela AG	2018	3
K203369	Avance Solo Negative Pressure Wound Therapy (NPWT) System	Molnlycke Health Care Us, LLC	2021	0
K160487	V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	Kci USA, Inc.	2016	0

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?

Its one ancestor has a recall.
Of its descendants, K133276 (Kci USA, Inc., 2013) has gone furthest, with 9 descendants of its own.
5 other devices also cite its predicate K100821.

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. 2012, 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 ActiVAC., InfoVAC., V.AC. ATS, V.AC. Freedom, V.AC. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. When used on open wounds, they are 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…

Read the full statement (142 words)

When used on open wounds, they are 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 exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dlehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, they are 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 exudates via the application of negative pressure wound therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120033

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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