510(k) · Cleared

Recalled · Class II · 2014

Renasys EZ

K082426510(k) SpecialCleared Sep 5, 200814-day reviewClass II21 CFR 878.4780Recalls 4

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 Sep 5, 2008 as substantially equivalent to K061919 (Blue Sky Medical Group Incorporated, 2007) after a 14-day review. Its family tree reaches back 4 generations to 1995. 58 later devices descend from it. It has been recalled 4 times.

Decided: Sep 5, 2008
Review: 14 days
Class: Class II
Product code: OMP
Recalls: 4
Predicates: 1

Its longest line of descent runs back 4 generations to K945062 (1995). 5 ancestors in all. 58 later devices descend from it, 3 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 deviceK082426 Renasys EZSmith & Nephew, Inc. · 2008
Descendant · cites it directly · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
Descendant · 2 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
Descendant · 2 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
Descendant · 3 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
Descendant · cites it directly · 15 of its ownK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2009high 7 (2018) · low 1 (2010)2026

Most influential descendants

Showing 5 of 58 · See all

K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · cites it directly56descendants
K111170PICOSmith & Nephew, Inc. · 2011 · 2 generations on26descendants
K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 2 generations on25descendants
K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 3 generations on23descendants
K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · cites it directly15descendants

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)	K082426	Renasys EZ	Smith & Nephew, Inc.	2008	—
+1	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
+2	K111170	PICO	Smith & Nephew, Inc.	2011	—
+2	K112127	Pico Single Use Negative Pressure Wound Therapy System	Smith & Nephew, Inc.	2012	—
+3	K151436	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical, Ltd.	2016	—
+1	K091470	Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059	Smith & Nephew, Inc.	2009	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2011	1	0
2012	3	0
2013	2	0
2014	1	0
2015	3	0
2016	5	0
2017	6	0
2018	7	0
2019	7	0
2020	3	0
2021	2	0
2022	6	0
2023	2	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K082426, 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

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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
*	K061919	Versatile 1 Ezcare Wound Vacuum System Summary page 1 …4780 Product Code; BTA Predicate Device Information Versatile 1 TM EZCare Wound Vacuum System cleared originally in k061919. Product Description The Renasys EZ is a powered suction pump with accessory wound dressing kits, disposable canister and filte…	Blue Sky Medical Group Incorporated	2007	1

Also cleared against K061919: 2 other devices →

What descends from it? (58)

See all 58

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

Number	Device	Applicant	Decided	Descendants
K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	56
K091470	Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059	Smith & Nephew, Inc.	2009	15
K113236	Foryou NPWT Device	Foryou Medical Electronics Co, Ltd.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 13, 2014	Class II	Z-2688-2014	No Marketing Application	Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Jul 18, 2014	Class II	Z-0040-2015	Device Design	RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Jul 18, 2014	Class II	Z-0041-2015	Device Design	RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Jul 18, 2014	Class II	Z-0039-2015	Device Design	RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

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 1.6 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K083375 (Smith & Nephew, Inc., 2009) has gone furthest, with 56 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?

The Renasys EZ is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082426 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082426: Renasys EZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082426

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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