510(k) · Cleared

Recalled · 2010

Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits

K082211510(k) TraditionalCleared Nov 14, 2008100-day reviewClass II21 CFR 878.4780Recalls 1

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

Smith & Nephew, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Nov 14, 2008 as substantially equivalent to K061919 (Blue Sky Medical Group Incorporated, 2007) and 1 other predicate after a 100-day review. Its family tree reaches back 4 generations to 1995. 68 later devices descend from it. It has been recalled once.

Decided: Nov 14, 2008
Review: 100 days
Class: Class II
Product code: OMP
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K945062 (1995). 7 ancestors in all. 68 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
3 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
2 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
1 generation backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
This deviceK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008
Descendant · cites it directly · 48 of its ownK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
Descendant · cites it directly · 31 of its ownK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
Descendant · 2 generations on · 21 of its ownK122132 Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad…Molnlycke Health Care · 2013
Descendant · 3 generations on · 14 of its ownK141847 Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015
Descendant · 2 generations on · 12 of its ownK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2010high 10 (2015) · low 0 (2020)2026

Most influential descendants

Showing 5 of 68 · See all

K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc. · 2011 · cites it directly48descendants
K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010 · cites it directly31descendants
K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care · 2013 · 2 generations on21descendants
K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC · 2015 · 3 generations on14descendants
K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc. · 2015 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
−3	K042134	Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2004	2
−2	K052456	Modification to Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2005	—
−1	K061919	Versatile 1 Ezcare Wound Vacuum System	Blue Sky Medical Group Incorporated	2007	1
0 (this device)	K082211	Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits	Smith & Nephew, Inc.	2008	—
+1	K110647	Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT…	Smith & Nephew, Inc.	2011	6
+1	K092992	A4-XLR8 Foam Dressing	Genadyne Biotechnologies, Inc.	2010	—
+2	K122132	Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium…	Molnlycke Health Care	2013	—
+3	K141847	Avance Foam Dressing Kits	Molnlycke Health Care Us, LLC	2015	—
+2	K142979	RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits…	Smith & Nephew, Inc.	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	0
2012	2	0
2013	3	0
2014	7	0
2015	10	0
2016	10	0
2017	2	0
2018	2	0
2019	7	0
2021	4	0
2022	5	0
2023	3	0
2024	4	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K082211, 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
*	K061919	Versatile 1 Ezcare Wound Vacuum System Summary page 1 …Code: Class II,BTA 4. Predicate Device Information: Versatile 1 EZCare Wound Vacuum System BlueSky Medical 510(k) #K061919 Antlia IITM Suction Pump System Innovative Therapies, Inc. 510(k) #K070904 5. Device…	Blue Sky Medical Group Incorporated	2007	1
*	K070904	Antlia II Suction Pump System Summary page 1 …ical 510(k) #K061919 Antlia IITM Suction Pump System Innovative Therapies, Inc. 510(k) #K070904 5. Device Description: The NPWT Foam Dressing Kits are a line extension to Smith & Nephew's current Chariker-JeterTM…	Innovative Therapies, Inc.	2007	—

Also cleared against K061919: 2 other devices →

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K110647	Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…	Smith & Nephew, Inc.	2011	48
K092992	A4-XLR8 Foam Dressing	Genadyne Biotechnologies, Inc.	2010	31
K132225	Extricare	Devon Medical, Inc.	2014	8
K140634	extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…	Devon Medical, Inc.	2014	4
K122490	Kulavac	CG Bio Co., Ltd.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 14, 2010	Not classified	Z-0875-2012	Nonconforming Material/Component	On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
2 of the 7 ancestors have a recall of any class.
Of its descendants, K110647 (Smith & Nephew, Inc., 2011) has gone furthest, with 48 descendants of its own.
2 other devices also cite its predicate K061919.

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. 2008, 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?

RenasysTM -F NPWT Foam Dressing Kits are intended to be used In conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device partIcularly as the device may promote wound healing.

NPWT is appropriate for use on the following wounds:

• Pressure ulcers

• Diabetic/neuropathic ulcers

• Venous insufficiency ulcers

• Traumatic wounds

• Post-operative and dehisced surgical wounds

• Explored fistulas

• Skin flaps and grafts

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082211 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082211

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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