510(k) · Cleared

Cleared

V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10

K063426510(k) SpecialCleared Dec 13, 200630-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 Dec 13, 2006 as substantially equivalent to K032310 (Kinetic Concepts, Inc., 2003) after a 30-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.

Decided: Dec 13, 2006
Review: 30 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K945062 (1995). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
1 generation backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
This deviceK063426 V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5…Kci USA, Inc. · 2006
Descendant · cites it directly · 1 of its ownK063740 V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766Kci USA, Inc. · 2007 · Recalled
Descendant · 2 generations on · 0 of its ownK160487 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all

K063740V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766Kci USA, Inc. · 2007 · cites it directly1descendant
K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. · 2016 · 2 generations on0descendants

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	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	2
0 (this device)	K063426	V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10	Kci USA, Inc.	2006	—
+1	K063740	V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766	Kci USA, Inc.	2007	4
+2	K160487	V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	Kci USA, Inc.	2016	—

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
2007	1	0
2016	1	0

FIG. 1 — Lineage of K063426, 1995–2016Source: 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
*	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats Summary page 1 …Powered suction pump The predicate product is the 500 mL V.A.C.® ATS Canister With Gel, described under K032310. This canister is a component of the V.A.C.® ATS Therapy Unit which was included inthe V.A.C.®…	Kinetic Concepts, Inc.	2003	2

Also cleared against K032310: 13 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063740	V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766	Kci USA, Inc.	2007	1

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 11 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K063740 (Kci USA, Inc., 2007) 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.([!J 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 V.A.C.gI} GranuFoam4ll 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/K063426 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063426: V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063426

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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