510(k) Report

510(k) · Cleared

Cleared

V.A.C.ULTA Negative Pressure Wound Therapy System

K203316510(k) TraditionalCleared Oct 27, 2021351-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

Kci, A Part of 3M Health Care Business Group · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Oct 27, 2021 as substantially equivalent to K162790 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2017) after a 351-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.

Decided
Oct 27, 2021
Review
351 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K945062 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
  3. 3 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
  4. 2 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
  5. 1 generation backK162790 V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2017 · Recalled
  6. This deviceK203316 V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group · 2021
  7. Descendant · cites it directly · 0 of its ownK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945062VacplusKinetic Concepts, Inc.1995—
−4K971548AmbuvacKinetic Concepts, Inc.1997—
−3K021501V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc.2002—
−2K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.)2010—
−1K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20171
0 (this device)K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group2021—
+1K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K203316, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K162790V.A.C.ULTA Negative Pressure Wound Therapy System
Summary page 4
…ed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] V.A.C.® Ulta Negative Pressure Wound Therapy System (K162790) K203316 51…
Kci USA, Inc. (Kinetic Concepts, Inc.)20171

Also cleared against K162790: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260

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 26 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K261338 (Smith & Nephew Medical, Ltd., 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K162790.

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. 2021, this device’s year, is highlighted.

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.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy). • V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation…

Read the full statement (252 words)

The V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy).

• V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

• Veraflo™ Therapy 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.® Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

V.A.C.® Therapy in the absence of instillation may also be used for:

o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K203316: V.A.C.ULTA Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203316

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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