510(k) · Cleared
ClearedExsudex Wound Drainage Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Medical Company · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 8, 2008 as substantially equivalent to K992448 (Kinetic Concepts, Inc., 2000) and 3 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 8, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945062 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 1 generation backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- This deviceK082311 Exsudex Wound Drainage PumpThe Medical Company · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −1 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| 0 (this device) | K082311 | Exsudex Wound Drainage Pump | The Medical Company | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
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? (4)
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 |
|---|---|---|---|
| * | K992448 | V.a.C. PlusSummary page 2…T ii. Classification name: Powered suction pump (per 21 CFR 878.4780) iii. Substantial equivalence: V.A.C." Plus 510(k) No.K992448 Ambulatory V.A.C. 510(k) No.1K971548… | 2000 |
| * | K971548 | AmbuvacSummary page 2…iii. Substantial equivalence: V.A.C." Plus 510(k) No.K992448 Ambulatory V.A.C. 510(k) No.1K971548 Medela Vario 5 10(k) No. K983552… | 1997 |
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 2…Ambulatory V.A.C. 510(k) No.1K971548 Medela Vario 5 10(k) No. K983552 Versatile 1 510(k) No. K052456 iv. Device description: The ExsudexTM… | 1999 |
| * | K052456 | Modification to Versatile 1 Wound Vacuum SystemSummary page 2…71548 Medela Vario 5 10(k) No. K983552 Versatile 1 510(k) No. K052456 iv. Device description: The ExsudexTM unit is a compact portable suction device that can be powered by either an internal… | 2005 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K992448.
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. 2008, this device’s year, is highlighted.
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 Exsudex™ Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient's bedside particularly as the device may promote wound healing .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082311: Exsudex Wound Drainage Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082311
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