510(k) Report

510(k) · Cleared

Cleared

V.a.C. Instillamat (Vacuum Assisted Closure Instillamat

K021501510(k) TraditionalCleared Dec 2, 2002207-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 Dec 2, 2002 as substantially equivalent to K992448 (Kinetic Concepts, Inc., 2000) and 1 other predicate after a 207-day review. Its family tree reaches back 2 generations to 1995. 30 later devices descend from it.

Decided
Dec 2, 2002
Review
207 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K945062 (1995). 3 ancestors in all. 30 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2006: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2009: 3 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2015: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2016: 3 descendants cleared2021: 3 descendants cleared2024: 2 descendants cleared2019: 2 descendants cleared2018: 2 descendants cleared2026: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant clearedK945062 · Vacplus · Kinetic Concepts, Inc. · 1995K971548 · Ambuvac · Kinetic Concepts, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 5 descendants K971548 · Ambuvac · Kinetic Concepts, Inc. · 1997K945062 · Vacplus · Kinetic Concepts, Inc. · 19950+5
  1. Root · 2 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 1 generation backK971548 AmbuvacKinetic Concepts, Inc. · 1997
  3. This deviceK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
  4. Descendant · cites it directly · 19 of its ownK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
  5. Descendant · 2 generations on · 10 of its ownK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
  6. Descendant · 3 generations on · 9 of its ownK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
  7. Descendant · 3 generations on · 8 of its ownK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
  8. Descendant · 4 generations on · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12009: 32010: 12011: 12012: 12013: 12015: 22016: 32017: 12018: 22019: 22020: 12021: 32022: 12023: 22024: 22026: 1
2006high 3 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all
  • K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010 · cites it directly19descendants
  • K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015 · 2 generations on10descendants
  • K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc. · 2016 · 3 generations on9descendants
  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016 · 3 generations on8descendants
  • K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc. · 2018 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945062VacplusKinetic Concepts, Inc.1995—
−1K971548AmbuvacKinetic Concepts, Inc.1997—
0 (this device)K021501V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc.2002—
+1K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.)2010—
+2K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision…Kci USA, Inc. (Kinetic Concepts, Inc.)2015—
+3K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing…Kci USA, Inc.2016—
+3K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE…Kci USA, Inc. (Kinetic Concepts, Inc.)2016—
+4K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management…Kci USA, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200930
201010
201110
201210
201310
201520
201630
201710
201820
201920
202010
202130
202210
202320
202420
202610
FIG. 1 — Lineage of K021501, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K992448V.a.C. Plus
Summary page 1
…Contact: Judith Harbour 1-800-275-4524 IV. Substantial Equivalence: V.A.C. Plus 51O(k) No.K992448 Ambulatory V.A.C. 510(k) No.K971548 V, Description o f…
Kinetic Concepts, Inc.2000—
*K971548Ambuvac
Summary page 1
…V.A.C. Plus 51O(k) No.K992448 Ambulatory V.A.C. 510(k) No.K971548 V, Description o f Device The V.A.C. Instillamat device is a modified V.A.C. device manufactured by Kinetic Concepts…
Kinetic Concepts, Inc.1997—

Also cleared against K992448: 4 other devices →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.)201019
K071301Antlia I Wound Irrigation SystemInnovative Therapies, Inc.20073
K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20063
K060046DermastreamEnzysurge, Ltd.20061

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 7 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K100657 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2010) has gone furthest, with 19 descendants of its own.
  • 4 other devices also cite its predicate K992448.

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

2007: 62008: 82009: 82010: 62011: 62012: 112013: 112014: 102015: 202016: 192017: 112018: 132019: 152020: 62021: 92022: 102023: 82024: 92025: 52026 (partial year): 9
2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007: 113 days median2008: 98 days median2009: 87 days median2010: 97 days median2011: 123 days median2012: 292 days median2013: 84 days median2014: 179 days median2015: 189 days median2016: 146 days median2017: 137 days median2018: 214 days median2019: 249 days median2020: 179 days median2021: 238 days median2022: 229 days median2023: 291 days median2024: 181 days median2025: 127 days median2026 (partial year): 141 days median
2007high 292 (2012) · low 84 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OMP

2in 2024

2009: 72010: 32012: 12013: 22014: 42015: 12016: 22019: 12024: 2
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

2007: 12008: 12009: 792010: 802011: 1302012: 972013: 1692014: 2292015: 3782016: 3982017: 3682018: 4222019: 9942020: 3,6642021: 1,4222022: 2582023: 1432024: 1352025: 140
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611301
200889801
2009887779
2010697380
201161230130
201211292197
201311842169
2014101794229
2015201891378
2016191462398
2017111370368
2018132140422
2019152491994
2020617903,664
2021923801,422
2022102290258
202382910143
202491812135
202551270140
202691410—

What is it indicated for?

The V.A.C. Instillamat device is indicated for patients who would benefit from

vacuum assisted drainage and controlled delivery of topical wound treatment

solutions and suspensions over the wound bed.

The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and

dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

Indications for use as stated in the FDA summary.

Also cleared against K992448

4 other devices cite the same predicate.

  • K082311Exsudex Wound Drainage PumpThe Medical Company · 2008
  • K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 20032 recalls
  • K022011V.a.C. Abdominal DressingKinetic Concepts, Inc. · 20031 recall
  • K021500Vacuum Assisted ClosureKinetic Concepts, Inc. · 2002

More from Kinetic Concepts, Inc.

48 FDA decisions under this applicant name. See the company

  • K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
  • K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc. · 2005
  • K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 20032 recalls
  • K022011V.a.C. Abdominal DressingKinetic Concepts, Inc. · 20031 recall
  • K021500Vacuum Assisted ClosureKinetic Concepts, Inc. · 2002

Recent decisions in OMP

The OMP category page

  • K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)Smith & Nephew Medical, Ltd. · 2026
  • K260426MeCare Alpha (MCA2019)IVT Medical, Ltd. · 2026
  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026

https://510kreport.com/device/K021501 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021501: V.a.C. Instillamat (Vacuum Assisted Closure Instillamat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021501

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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