510(k) · Cleared

Recalled · 2006

V.a.C. Abdominal Dressing

K022011510(k) TraditionalCleared Feb 26, 2003252-day reviewClass II21 CFR 878.3300Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kinetic Concepts, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Feb 26, 2003 as substantially equivalent to K992448 (Kinetic Concepts, Inc., 2000) and 2 other predicates after a 252-day review. Its family tree reaches back 2 generations to 1995. 17 later devices descend from it. It has been recalled once.

Decided: Feb 26, 2003
Review: 252 days
Class: Class II
Product code: FTL
Recalls: 1
Predicates: 3

Its longest line of descent runs back 2 generations to K945062 (1995). 4 ancestors in all. 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
1 generation backK971548 AmbuvacKinetic Concepts, Inc. · 1997
This deviceK022011 V.a.C. Abdominal DressingKinetic Concepts, Inc. · 2003
Descendant · cites it directly · 11 of its ownK100787 Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc. · 2010
Descendant · 2 generations on · 10 of its ownK112784 Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011
Descendant · 3 generations on · 5 of its ownK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
Descendant · 4 generations on · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
Descendant · 3 generations on · 3 of its ownK130852 Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006high 4 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 17 · See all

K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc. · 2010 · cites it directly11descendants
K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011 · 2 generations on10descendants
K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc. · 2015 · 3 generations on5descendants
K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · 4 generations on3descendants
K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care · 2014 · 3 generations on3descendants

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)	K022011	V.a.C. Abdominal Dressing	Kinetic Concepts, Inc.	2003	—
+1	K100787	Renasys F/-AB Abdominal Wound Dressing Kit	Smith & Nephew, Inc.	2010	—
+2	K112784	Renasys AB Abominal Dressing Kit	Smith & Nephew, Inc.	2011	—
+3	K143133	RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal…	Smith & Nephew, Inc.	2015	—
+4	K181822	RENASYS Touch; RENASYS Y-Connector	Smith & Nephew Medical Limited	2019	—
+3	K130852	Avance® Foam Abdominal Dressing Kit	Molnlycke Health Care	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	2	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2019	4	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K022011, 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 FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 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? (3)

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 …June 7, 2002 4. Name of Device: V.A.C. Abdominal Dressing 5. Classification Name: Mesh, Surgical, Polymeric 21 CFR 878.3300 Class 11 6. Predicate Devices: V.A.C. Plus (K992448) Ambulatory V.A.C. (971548) Wittman-Patch™ (K983753) 7. Description of Device and Intended Use The V.A.C. Abdominal Dressing wi…	Kinetic Concepts, Inc.	2000	—
*	K971548	Ambuvac Summary page 2 …mmercially available devices: e V.A.C. previously cleared by the FDA in 1994 [510(k) No. K945062]. o Ambulatory V.A.C. previously cleared by the FDA in 1997 [510(k) No. K971548]. e V.A.C. Plus previously cleared by the FDA in 1999 [510(k) No. K992448] Page 2 of 2 V.A.C.® Abdominal Dressing 510(k) Summar…	Kinetic Concepts, Inc.	1997	—
*	K983753	Star Temporary Wound Cover Summary page 1 …sing 5. Classification Name: Mesh, Surgical, Polymeric 21 CFR 878.3300 Class 11 6. Predicate Devices: V.A.C. Plus (K992448) Ambulatory V.A.C. (971548) Wittman-Patch™ (K983753) 7. Description of Device and Intended Use The V.A.C. Abdominal Dressing will be provided in a kit to provide an easy, tailored…	Osteogenics, Inc.	1999	—

Also cleared against K992448: 4 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K100787	Renasys F/-AB Abdominal Wound Dressing Kit	Smith & Nephew, Inc.	2010	11
K062227	V.a.C. Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	2006	3
K090489	Abthera Open Abdomen Dressing, Model: M8275026	Kci USA, Inc.	2009	1
K083357	Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510	Kci USA, Inc.	2009	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 17, 2006	Not classified	Z-0873-06	Other	Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.

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 5.8 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K100787 (Smith & Nephew, Inc., 2010) has gone furthest, with 11 descendants of its own.
4 other devices also cite its predicate K992448.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

The V.A.C. Abdominal Dressing is a specialty dressing indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K022011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022011: V.a.C. Abdominal Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022011

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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