510(k) · Cleared

Cleared

Ambuvac

K971548510(k) TraditionalCleared May 22, 199724-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

Kinetic Concepts, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on May 22, 1997 as substantially equivalent to K945062 (Kinetic Concepts, Inc., 1995) after a 24-day review. Its family tree reaches back 1 generation to 1995. 156 later devices descend from it.

Decided: May 22, 1997
Review: 24 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945062 (1995). 156 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK945062 VacplusKinetic Concepts, Inc. · 1995
This deviceK971548 AmbuvacKinetic Concepts, Inc. · 1997
Descendant · cites it directly · 112 of its ownK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
Descendant · 2 generations on · 75 of its ownK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
Descendant · 2 generations on · 60 of its ownK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
Descendant · 3 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
Descendant · 3 generations on · 37 of its ownK080275 NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008

Showing 5 of 156 descendants. See all descendants

Descendants cleared per year

2002high 14 (2016) · low 0 (2004)2026

Most influential descendants

Showing 5 of 156 · See all

K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · cites it directly112descendants
K080357Medela Invia Wound TherapyMedela AG · 2008 · 2 generations on75descendants
K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · 2 generations on60descendants
K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 3 generations on56descendants
K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008 · 3 generations on37descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
0 (this device)	K971548	Ambuvac	Kinetic Concepts, Inc.	1997	—
+1	K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	2
+2	K080357	Medela Invia Wound Therapy	Medela AG	2008	1
+2	K063692	V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000	Kci USA, Inc.	2007	1
+3	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
+3	K080275	NPD 1000 Negative Pressure Wound Therapy System	Iasis Medical, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2005	3	0
2006	5	0
2007	5	0
2008	4	0
2009	7	0
2010	5	0
2011	5	0
2012	8	0
2013	6	0
2014	8	0
2015	7	0
2016	14	0
2017	9	0
2018	13	0
2019	14	0
2020	5	0
2021	6	0
2022	9	0
2023	5	0
2024	7	0
2025	3	0
2026	5	0

FIG. 1 — Lineage of K971548, 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
*	K945062	Vacplus Summary page 1 …ary KT 1543 L Name of Device: Ambulatory V.A.C I Classification Name: :’:cv:;r;:(é :‘;cg;;i”l]xg())])a MAY 2 2 1897 II1. Substantial Equivalence: V.A.C. Plus, 510(k) No. 945062 Iv. Device Description: The Ambulatory V.A.C. is a portable suction device that can be powered by a separate battery pack or a l…	Kinetic Concepts, Inc.	1995	—

Also cleared against K945062: 3 other devices →

What descends from it? (156)

See all 156

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

Number	Device	Applicant	Decided	Descendants
K032310	Mini V.a.C., V.a.C. Freedom, V.a.C. Ats	Kinetic Concepts, Inc.	2003	112
K021501	V.a.C. Instillamat (Vacuum Assisted Closure Instillamat	Kinetic Concepts, Inc.	2002	30
K022011	V.a.C. Abdominal Dressing	Kinetic Concepts, Inc.	2003	17
K062456	Novaspine Powered Suction Pump Pro-1	Novaspine, LLC	2006	16
K113291	Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…	Simex Medizintechnik GmbH	2012	4
K082311	Exsudex Wound Drainage Pump	The Medical Company	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K032310 (Kinetic Concepts, Inc., 2003) has gone furthest, with 112 descendants of its own.
3 other devices also cite its predicate K945062.

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.

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 Ambulatory v.~.C .. device is indicate~ f~r patien~~ who whould benefit from a suction device; particularly as the device use may promote wound healing, including for patients who wocld benefit from vacuum-assisted drainage and removal of inf~ctious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971548 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971548: Ambuvac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971548

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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