510(k) · Cleared
ClearedVacuum Assisted Closure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Dec 20, 2002 as substantially equivalent to K945062 (Kinetic Concepts, Inc., 1995) and 1 other predicate after a 225-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 20, 2002
- Review
- 225 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945062 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K945062 | VacplusSummary page 1…Contact: Judith Barbow 1-800-275-4524 IV. Substantial Equivalence: V.A.C. 510(k) No.K945062 V.A.C. PLUS 510(k) No.K99;!448 V. Descr… | 1995 |
| * | K992448 | V.a.C. PlusSummary page 1…an addilional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) NoK992448. V. Indications for Use The V,A,C,@Sysleni is a powered suction punip system that is intended for use o… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 4.8 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K945062.
How does its category compare?
All OMP devicesOMP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 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 V.A.C.® System is a powered suction pump system that is intended for use
on patients who would benefit from a suction device, particularly as the device
may promote wound* healing, including patients who would benefit from
vacuum assisted drainage and removal of infectious material or other fluids
from wounds under the influence of continuous and/or alternating suction
pressures.
"The V.A.C. is intended for patients with chronic, acute, traumatic, subacute
and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers,
flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021500: Vacuum Assisted Closure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021500
Report an extraction error
Are you the manufacturer?
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