510(k) · Cleared
ClearedNisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cork Medical Products, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 24, 2014 as substantially equivalent to K082676 (Genadyne Biotechnologies, Inc., 2008) and 1 other predicate after a 294-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Oct 24, 2014
- Review
- 294 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945062 (1995). 11 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 2 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- This deviceK140022 Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister…Cork Medical Products, LLC · 2014
- Descendant · cites it directly · 1 of its ownK243187 Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical · 2025
- Descendant · cites it directly · 1 of its ownK230677 Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical · 2023
- Descendant · 2 generations on · 0 of its ownK261291 Nisus NPWT Canister 500-mL (CPC-500)Cork Medical · 2026
- Descendant · 2 generations on · 0 of its ownK241061 VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical · 2024
- Descendant · cites it directly · 0 of its ownK203693 Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC · 2021
Most influential descendants
Showing 5 of 5 · See all- K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical · 2025 · cites it directly1descendant
- K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical · 2023 · cites it directly1descendant
- K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical · 2026 · 2 generations on0descendants
- K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical · 2024 · 2 generations on0descendants
- K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −2 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| 0 (this device) | K140022 | Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus… | Cork Medical Products, LLC | 2014 | — |
| +1 | K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025 | — |
| +1 | K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | 2023 | — |
| +2 | K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026 | — |
| +2 | K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024 | — |
| +1 | K203693 | Nisus Touch Negative Pressure Wound Therapy Pump | Cork Medical Products, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K082676 | Genadyne A4 Wound Vacuum SystemSummary page 4…Company Brand Name 510(k) Number Genadyne A4 Wound Dressing Vacuum System Kit K082676 Biotechnologies, Inc. Genadyne A4-XLR8 Foam Dressing K092992 Biotechnologie… | 2008 |
| * | K092992 | A4-XLR8 Foam DressingSummary page 4…A4 Wound Dressing Vacuum System Kit K082676 Biotechnologies, Inc. Genadyne A4-XLR8 Foam Dressing K092992 Biotechnologies, Inc. DEVICE DESCRIPTION 807.92(a)(4) Cork Medical Pr… | 2010 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K243187 (Cork Medical, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K082676.
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. 2014, 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 Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates. infectious material, and tissue debris.
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/K140022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140022: Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140022
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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