510(k) · Cleared

Recalled · Class II · 2014

Modification to Renasys EZ Plus Negative Pressure Wound Therapy

K102001510(k) SpecialCleared Aug 6, 201022-day reviewClass II21 CFR 878.4780Recalls 3

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 Aug 6, 2010 as substantially equivalent to K091470 (Smith & Nephew, Inc., 2009) after a 22-day review. Its family tree reaches back 7 generations to 1995. 14 later devices descend from it. It has been recalled 3 times.

Decided: Aug 6, 2010
Review: 22 days
Class: Class II
Product code: OMP
Recalls: 3
Predicates: 1

Its longest line of descent runs back 7 generations to K945062 (1995). 18 ancestors in all, the oldest K933902 (1994). 14 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
3 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
2 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
1 generation backK091470 Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc. · 2009 · Recalled
This deviceK102001 Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc. · 2010
Descendant · cites it directly · 13 of its ownK132446 Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013
Descendant · cites it directly · 12 of its ownK142979 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · 2 generations on · 5 of its ownK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
Descendant · cites it directly · 5 of its ownK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013high 3 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all

K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc. · 2013 · cites it directly13descendants
K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc. · 2015 · cites it directly12descendants
K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016 · 2 generations on5descendants
K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc. · 2015 · cites it directly5descendants
K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
−6	K042134	Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2004	2
−5	K052456	Modification to Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2005	—
−4	K061919	Versatile 1 Ezcare Wound Vacuum System	Blue Sky Medical Group Incorporated	2007	1
−3	K082426	Renasys EZ	Smith & Nephew, Inc.	2008	4
−2	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
−1	K091470	Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059	Smith & Nephew, Inc.	2009	1
0 (this device)	K102001	Modification to Renasys EZ Plus Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2010	—
+1	K132446	Renasys EZ Max Negative Pressure Wound Therapy Device	Smith & Nephew, Inc.	2013	—
+1	K142979	RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits…	Smith & Nephew, Inc.	2015	1
+2	K153209	RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters…	Smith & Nephew Medical, Ltd.	2016	—
+1	K143133	RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal…	Smith & Nephew, Inc.	2015	—
+2	K181822	RENASYS Touch; RENASYS Y-Connector	Smith & Nephew Medical Limited	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0
1999	1	0
2000	1	0
2002	1	0
2003	1	0
2005	1	0
2006	2	0
2007	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	3	0
2016	2	0
2019	2	0
2022	2	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K102001, 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
*	K091470	Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 Summary page 1 …Product Code: OMP Predicate Device Information 510(k) # Device Clearance Date K091470 RenaSysTm EZ 07/09/2009 Device Description The Renasys EZ PLUS NPWT device is a li…	Smith & Nephew, Inc.	2009	1

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K132446	Renasys EZ Max Negative Pressure Wound Therapy Device	Smith & Nephew, Inc.	2013	13
K142979	RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…	Smith & Nephew, Inc.	2015	12
K143133	RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…	Smith & Nephew, Inc.	2015	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
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 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
9 of the 18 ancestors have a recall of any class.
Of its descendants, K132446 (Smith & Nephew, Inc., 2013) has gone furthest, with 13 descendants of its own.

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. 2010, 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 PLUS is indicated for patients who would benefit from a suction device

(negative pressure wound therapy) as it may promote wound healing via removal of fluids,

including irrigation and body fluids, wound exudates and infectious materials,

Examples of appropriate wound types include:

* Chronic

* Acute

* Traumatic

* Sub-acute and dehisced wounds

* Ulcers (such as pressure or diabetic)

* Partial-thickness burns

* Flaps and grafts

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102001 · printed Nov 3, 2026

Cite this page

510(k) Report. “K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102001

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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