510(k) · Cleared

Recalled · Class II · 2016

Versatile 1 Ezcare Wound Vacuum System

K061919510(k) TraditionalCleared Feb 5, 2007214-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

Blue Sky Medical Group Incorporated · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Feb 5, 2007 as substantially equivalent to K042134 (Blue Sky Medical Group Incorporated, 2004) and 1 other predicate after a 214-day review. Its family tree reaches back 3 generations to 1995. 107 later devices descend from it. It has been recalled once.

Decided: Feb 5, 2007
Review: 214 days
Class: Class II
Product code: OMP
Recalls: 1
Predicates: 2

Its longest line of descent runs back 3 generations to K945062 (1995). 4 ancestors in all. 107 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
2 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
1 generation backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
This deviceK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007
Descendant · cites it directly · 68 of its ownK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
Descendant · cites it directly · 58 of its ownK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
Descendant · 2 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
Descendant · 2 generations on · 48 of its ownK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
Descendant · 2 generations on · 31 of its ownK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2008high 14 (2016) · low 2 (2008)2026

Most influential descendants

Showing 5 of 107 · See all

K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · cites it directly68descendants
K082426Renasys EZSmith & Nephew, Inc. · 2008 · cites it directly58descendants
K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 2 generations on56descendants
K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc. · 2011 · 2 generations on48descendants
K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010 · 2 generations on31descendants

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	K042134	Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2004	2
−1	K052456	Modification to Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2005	—
0 (this device)	K061919	Versatile 1 Ezcare Wound Vacuum System	Blue Sky Medical Group Incorporated	2007	—
+1	K082211	Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits	Smith & Nephew, Inc.	2008	1
+1	K082426	Renasys EZ	Smith & Nephew, Inc.	2008	4
+2	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
+2	K110647	Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT…	Smith & Nephew, Inc.	2011	6
+2	K092992	A4-XLR8 Foam Dressing	Genadyne Biotechnologies, Inc.	2010	—

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
2008	2	0
2009	3	0
2010	2	0
2011	3	0
2012	5	0
2013	5	0
2014	8	0
2015	10	0
2016	14	0
2017	7	0
2018	7	0
2019	10	0
2020	3	0
2021	5	0
2022	7	0
2023	4	0
2024	4	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K061919, 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
*	K042134	Versatile 1 Wound Vacuum System Summary page 1 …1 CFR 878.4780, Product Code BTA) Predicate Device Information Versatile 1 TM Wound Vacuum System cleared originally in K042134 (November 15, 2004) and amended in K052456 (November 4, 2005). Product Description The product is a portable suction pump that ma…	Blue Sky Medical Group Incorporated	2004	2
*	K052456	Modification to Versatile 1 Wound Vacuum System Summary page 1 …878.4780, Product Code BTA) Predicate Device Information Versatile 1 TM Wound Vacuum System cleared originally in K042134 (November 15, 2004) and amended in K052456 (November 4, 2005). Product Description The product is a portable suction pump that may promote wound healing when used with acce…	Blue Sky Medical Group Incorporated	2005	—

Also cleared against K042134: 9 other devices →

What descends from it? (107)

See all 107

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

Number	Device	Applicant	Decided	Descendants
K082211	Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits	Smith & Nephew, Inc.	2008	68
K082426	Renasys EZ	Smith & Nephew, Inc.	2008	58
K090258	Venturi NPWT V. II Advanced Vacuum System	Talley Medical	2009	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 21, 2016	Class II	Z-2848-2016	Unknown/Undetermined by firm	Sterility seal integrity failures on the Renasys Sterile Transparent Film

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K082211 (Smith & Nephew, Inc., 2008) has gone furthest, with 68 descendants of its own.
9 other devices also cite its predicate K042134.

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. 2007, 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 Versatile 1 EZCare TM Wound Vacuum System 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/K061919 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061919: Versatile 1 Ezcare Wound Vacuum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061919

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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