510(k) · Cleared

Recalled · Class II · 2025

V.a.C. Therapy System

K062227510(k) TraditionalCleared Oct 4, 200663-day reviewClass II21 CFR 878.4780Recalls 2

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 Oct 4, 2006 as substantially equivalent to K032310 (Kinetic Concepts, Inc., 2003) and 3 other predicates after a 63-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it. It has been recalled 2 times.

Decided: Oct 4, 2006
Review: 63 days
Class: Class II
Product code: OMP
Recalls: 2
Predicates: 4

Its longest line of descent runs back 6 generations to K914575 (1991). 17 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
5 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
4 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
3 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
2 generations backK050261 V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
1 generation backK053627 Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc. · 2006
This deviceK062227 V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006
Descendant · cites it directly · 1 of its ownK083357 Open Abdomen Negative Pressure Therapy System, Model 370502…Kci USA, Inc. · 2009
Descendant · cites it directly · 0 of its ownK121817 Vcare aIVT Medical, Ltd. · 2013
Descendant · 2 generations on · 0 of its ownK120499 Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012

Most influential descendants

Showing 3 of 3 · See all

K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc. · 2009 · cites it directly1descendant
K121817Vcare aIVT Medical, Ltd. · 2013 · cites it directly0descendants
K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K914575	Sorbsan Topical Wound Dressing (Modified)	Dow B. Hickam, Inc.	1991	—
−5	K983210	Algisite M	Smith & Nephew, Inc.	1998	—
−4	K002896	Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing	The Westaim Corp.	2001	—
−3	K024298	Antimicrobial Alginate Dressing	Advanced Medical Solutions, Ltd.	2003	—
−2	K050261	V.a.C. Granufoam Silver Protection Dressing	Kinetic Concepts, Inc.	2005	—
−1	K053627	Modification to: V.a.C. Granufoam Silver Protection Dressing	Kci USA, Inc.	2006	—
0 (this device)	K062227	V.a.C. Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2006	—
+1	K083357	Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model…	Kci USA, Inc.	2009	—
+1	K121817	Vcare a	IVT Medical, Ltd.	2013	—
+2	K120499	Abthera Open Abdomen Negative Pressure Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1997	1	0
1999	1	0
2000	3	0
2002	1	0
2003	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2013	1	0

FIG. 1 — Lineage of K062227, 1991–2013Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats Summary page 1 …osable ' components), which were most recently cleared under "devicalentowhic e /~{ ': is- laimencei 510(k)s: K032310 (V.A.C. ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit),…	Kinetic Concepts, Inc.	2003	2
*	K021501	V.a.C. Instillamat (Vacuum Assisted Closure Instillamat Summary page 1 …r "devicalentowhic e /~{ ': is- laimencei 510(k)s: K032310 (V.A.C. ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (VA.C.® GranuFoam® Silver Protection Dressing)…	Kinetic Concepts, Inc.	2002	—
*	K053627	Modification to: V.a.C. Granufoam Silver Protection Dressing Summary page 1 …510(k)s: K032310 (V.A.C. ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (VA.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C. ® Abdominal Dressing).…	Kci USA, Inc.	2006	—
*	K022011	V.a.C. Abdominal Dressing Summary page 1 …Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (VA.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C. ® Abdominal Dressing). The components of the V.A.C.0 Therapy System work as an…	Kinetic Concepts, Inc.	2003	1

Also cleared against K032310: 13 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K083357	Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510	Kci USA, Inc.	2009	1
K121817	Vcare a	IVT Medical, Ltd.	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 17, 2025	Class II	Z-1176-2025	Device Design	Due to increase in complaints related to leak alarms
Nov 4, 2009	Not classified	Z-0666-2010	Nonconforming Material/Component	Power cords may crack and fail inside plug with potential for fire hazard.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
3 of the 17 ancestors have a recall of any class.
Of its descendants, K083357 (Kci USA, Inc., 2009) has gone furthest, with 1 descendant of its own.
13 other devices also cite its predicate K032310.

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.

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 VAC. Therapy System 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 exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The VAC. GranuFoam Silver Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062227 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062227: V.a.C. Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062227

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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