510(k) · Cleared
ClearedNisus NPWT Canister 500-mL (CPC-500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cork Medical · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on May 21, 2026 as substantially equivalent to K243187 (Cork Medical, 2025) after a 31-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- May 21, 2026
- Review
- 31 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945062 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 6 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 5 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 4 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- 2 generations backK140022 Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister…Cork Medical Products, LLC · 2014
- 1 generation backK243187 Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical · 2025
- This deviceK261291 Nisus NPWT Canister 500-mL (CPC-500)Cork Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −6 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −5 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −4 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026 | — |
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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Summary page 5…OMP PANEL General & Plastic Surgery PREDICATE DEVICE Nisus ONE Negative Pressure Wound Therapy System (K243187) DEVICE DESCRIPTION: The Nisus NPWT Canister 500-mL (CPC-500) is a disposable canister intended for use with negative pressure… | 2025 |
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 31 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
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. 2026, 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 NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management.
The Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)
The systems consist of a negative pressure wound therapy unit, dressings, tubing, and disposable canisters, including available canister configurations up to 500 mL capacity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261291 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261291: Nisus NPWT Canister 500-mL (CPC-500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261291
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026