510(k) · Cleared

Cleared

Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters

K142626510(k) TraditionalCleared Jun 12, 2015269-day reviewClass II21 CFR 878.4780

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

Medela AG · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Jun 12, 2015 as substantially equivalent to K080357 (Medela AG, 2008) after a 269-day review. Its family tree reaches back 4 generations to 1995. 12 later devices descend from it.

Decided: Jun 12, 2015
Review: 269 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K945062 (1995). 10 ancestors in all, the oldest K933902 (1994). 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
2 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
1 generation backK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
This deviceK142626 Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty…Medela AG · 2015
Descendant · cites it directly · 5 of its ownK153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016
Descendant · 2 generations on · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019
Descendant · cites it directly · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
Descendant · 3 generations on · 2 of its ownK223041 Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · Recalled
Descendant · cites it directly · 2 of its ownK151872 Avance Y-Connector SMolnlycke Health Care Us, LLC · 2015

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2015high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 12 · See all

K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd. · 2016 · cites it directly5descendants
K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · 2 generations on3descendants
K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · cites it directly3descendants
K223041Renasys Edge (66803126)Smith & Nephew Medical Limited · 2022 · 3 generations on2descendants
K151872Avance Y-Connector SMolnlycke Health Care Us, LLC · 2015 · cites it directly2descendants

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	K971548	Ambuvac	Kinetic Concepts, Inc.	1997	—
−2	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	2
−1	K080357	Medela Invia Wound Therapy	Medela AG	2008	1
0 (this device)	K142626	Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing…	Medela AG	2015	—
+1	K153209	RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters…	Smith & Nephew Medical, Ltd.	2016	—
+2	K181822	RENASYS Touch; RENASYS Y-Connector	Smith & Nephew Medical Limited	2019	—
+1	K172145	Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound…	Medela AG	2018	—
+3	K223041	Renasys Edge (66803126)	Smith & Nephew Medical Limited	2022	3
+1	K151872	Avance Y-Connector S	Molnlycke Health Care Us, LLC	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1999	1	0
2000	1	0
2002	1	0
2005	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	2	0
2018	1	0
2019	2	0
2022	2	0
2023	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K142626, 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? (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
*	K080357	Medela Invia Wound Therapy Summary page 4 …ON/USUAL NAME: Negative Pressure Wound Therapy Pump and Accessories CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: OMP PREDICATE DEVICE(S): K080357 Invia Wound Therapy K142626, Page 2 of…	Medela AG	2008	1
†	K113678	Invia Motion Negative Pressure Wound Therapy System	Medela AG	2012	—
†	K141847	Avance Foam Dressing Kits	Molnlycke Health Care Us, LLC	2015	—

Also cleared against K080357: 6 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K153209	RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…	Smith & Nephew Medical, Ltd.	2016	5
K172145	Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…	Medela AG	2018	3
K151872	Avance Y-Connector S	Molnlycke Health Care Us, LLC	2015	2

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
4 of the 10 ancestors have a recall of any class.
Of its descendants, K153209 (Smith & Nephew Medical, Ltd., 2016) has gone furthest, with 5 descendants of its own.
6 other devices also cite its predicate K080357.

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. 2015, 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 Medela® Invia Liberty Negative Pressure Wound Therapy System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142626: Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142626

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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