510(k) · Cleared

Recalled · 2005

Mini V.a.C., V.a.C. Freedom, V.a.C. Ats

K032310510(k) TraditionalCleared Oct 10, 200374-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

Kinetic Concepts, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Oct 10, 2003 as substantially equivalent to K992448 (Kinetic Concepts, Inc., 2000) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1995. 112 later devices descend from it. It has been recalled 2 times.

Decided: Oct 10, 2003
Review: 74 days
Class: Class II
Product code: OMP
Recalls: 2
Predicates: 2

Its longest line of descent runs back 2 generations to K945062 (1995). 3 ancestors in all. 112 later devices descend from it, 14 citing it directly.

By dateBy generation

Root · 2 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
1 generation backK971548 AmbuvacKinetic Concepts, Inc. · 1997
This deviceK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003
Descendant · cites it directly · 75 of its ownK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
Descendant · cites it directly · 60 of its ownK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
Descendant · 2 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
Descendant · 2 generations on · 37 of its ownK080275 NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008
Descendant · 3 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2005high 9 (2016) · low 3 (2005)2026

Most influential descendants

Showing 5 of 112 · See all

K080357Medela Invia Wound TherapyMedela AG · 2008 · cites it directly75descendants
K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · cites it directly60descendants
K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 2 generations on56descendants
K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008 · 2 generations on37descendants
K111170PICOSmith & Nephew, Inc. · 2011 · 3 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
−1	K971548	Ambuvac	Kinetic Concepts, Inc.	1997	—
0 (this device)	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	—
+1	K080357	Medela Invia Wound Therapy	Medela AG	2008	1
+1	K063692	V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000	Kci USA, Inc.	2007	1
+2	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
+2	K080275	NPD 1000 Negative Pressure Wound Therapy System	Iasis Medical, Inc.	2008	—
+3	K111170	PICO	Smith & Nephew, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2006	3	0
2007	4	0
2008	3	0
2009	4	0
2010	3	0
2011	3	0
2012	6	0
2013	6	0
2014	7	0
2015	5	0
2016	9	0
2017	8	0
2018	9	0
2019	9	0
2020	4	0
2021	3	0
2022	8	0
2023	3	0
2024	5	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K032310, 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K992448	V.a.C. Plus Summary page 1 …Contact: Judith Harbour 1-800-275-4524 IV. Substantial Equivalence: - V.A.C. Plus 510(k) No.K992448 Ambulatory V.A.C. 510(k)No.K971548 V. Description of Devi…	Kinetic Concepts, Inc.	2000	—
*	K971548	Ambuvac Summary page 1 …V.A.C. Plus 510(k) No.K992448 Ambulatory V.A.C. 510(k)No.K971548 V. Description of Device All models of the VAC family of devices, including the V.A.C.43 ATSTM,mini V.A.C.0, and the V.…	Kinetic Concepts, Inc.	1997	—

Also cleared against K992448: 4 other devices →

What descends from it? (112)

See all 112

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

Number	Device	Applicant	Decided	Descendants
K080357	Medela Invia Wound Therapy	Medela AG	2008	75
K063692	V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000	Kci USA, Inc.	2007	60
K132225	Extricare	Devon Medical, Inc.	2014	8
K041642	V.a.C. Granufoam Silver Dressing	Kinetic Concepts, Inc.	2005	8
K050261	V.a.C. Granufoam Silver Protection Dressing	Kinetic Concepts, Inc.	2005	7
K050129	Celleration Mist Therapy System 5.1	Celleration, Inc.	2005	6
K062227	V.a.C. Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2006	3
K063426	V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10	Kci USA, Inc.	2006	2
K063740	V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766	Kci USA, Inc.	2007	1
K211571	Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit	Zhejiang Longterm Medical Technology Co., Ltd.	2022	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 16, 2005	Not classified	Z-0379-06	Other	Possible mislabeling of shipping cartons.
Sep 21, 2004	Not classified	Z-0038-05	Other	The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.4 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K080357 (Medela AG, 2008) has gone furthest, with 75 descendants of its own.
4 other devices also cite its predicate K992448.

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 V.A.C.® family of devices with wound site feedback control are negative pressure devices used 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. Feedback control is achieved by measuring the level of negative pressure at the wound site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032310

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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