Nisus NPWT Canister 500-mL (CPC-500)
Device Facts
| Record ID | K261291 |
|---|---|
| Device Name | Nisus NPWT Canister 500-mL (CPC-500) |
| Applicant | Cork Medical |
| Product Code | OMP · General, Plastic Surgery |
| Decision Date | May 21, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Negative pressure wound therapy (NPWT) system; includes pump unit, tubing, dressings, and disposable 500-mL canister. Pump generates controlled negative pressure to facilitate wound management; exudate collected in passive, non-powered disposable canister. Used in professional healthcare facilities and home environments. Healthcare provider or patient operates system; monitors output via pump interface. System benefits patients by managing wound exudate and providing negative pressure therapy. Modification adds 500-mL canister compatibility; no changes to operating principles or energy delivery.
Clinical Evidence
Bench testing only. Verification testing included leak, block, and canister-full alarm testing, 3-day functionality, flow rate, battery runtime, and pressure testing (40-200 mmHg) using simulated wound exudate. Results met all predefined acceptance criteria.
Technological Characteristics
Powered suction pump; delivers controlled negative pressure. Disposable 500-mL canister made of medical-grade polymer with hydrophobic filter. Mechanical interface uses defined connector geometry and latch system. Non-sterile, single-use canister. Electrical safety per IEC 60601-1.
Indications for Use
Indicated for patients benefiting from negative pressure wound therapy for wound management. Intended for use only with Cork NPWT Wound Dressing Kit (K132004).
Regulatory Classification
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Predicate Devices
- Nisus ONE Negative Pressure Wound Therapy System (K243187)
Reference Devices
- Cork NPWT Wound Dressing Kit (K132004)
- Cork NPWT System (K140022)
- Nisus Touch Negative Pressure Wound Therapy Pump (K203693)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 21, 2026
Cork Medical
Antonio Williams
Regulatory Engineer
8000 Castleway Dr.
Indianapolis, Indiana 46112
Re: K261291
Trade/Device Name: Cork Medical Products Nisus Negative Pressure Wound Therapy System and Nisus Touch Negative Pressure Wound Therapy Pump
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump
Regulatory Class: Class II
Product Code: OMP
Dated: April 19, 2026
Received: April 20, 2026
Dear Antonio Williams:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261291 - Antonio Williams
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
{2}
K261291 - Antonio Williams
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K261291 | |
| Device Name Cork Medical Products Nisus Negative Pressure Wound Therapy System and Nisus Touch Negative Pressure Wound Therapy Pump | |
| Indications for Use (Describe) 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. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
{4}
K261291
510(k) Summary
[as required by 21 CFR 807.92(c)]
| DATE PREPARED | 31 March 2026 |
| --- | --- |
| APPLICANT | Cork Medical 8000 Castleway Drive Indianapolis, IN 46250 |
| REGISTRATION NUMBER | 3010588638 |
| CONTACT | Antonio Williams Regulatory Engineer Phone:317-361-4387 Email: awilliams@corkmedical.com |
| TRADE NAME | Cork Medical Products Nisus Negative Pressure Wound Therapy System and Nisus Touch Negative Pressure Wound Therapy Pump |
| COMMON NAME | Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump |
| MODEL NUMBER | CMPP-100 and TCMPP-100 |
| REGULATORY NUMBER | Class II |
| DEVICE CLASSIFICATION | 21 CFR 878.4780 |
| CLASSIFICATION NAME | Powered Suction Pump |
| PRODUCT CODE | 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 wound therapy (NPWT) systems for the collection of wound exudate. The canister mechanically interfaces with compatible NPWT pump systems and connects to wound dressings via standard tubing and connectors.
The device is provided as a single-use, non-sterile product and is packaged in a flexible packaging system.
The Nisus NPWT Canister 500-mL (CPC-500) has the same intended use, fundamental scientific technology, and performance characteristics as the legally marketed predicate device. The device differs only in canister volume and minor dimensional attributes necessary to achieve the 500-mL capacity. These differences do not affect the safety or effectiveness of the device.
The materials of construction and method of operation are equivalent to those of the predicate device.
INTENDED USE/INDICATION FOR USE:
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 NPWT System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)
Page 1 of 4
{5}
K261291
The systems consist of a negative pressure wound therapy unit, dressings, tubing, and disposable canisters, including available canister configurations up to 500-mL capacity.
## DESCRIPTION OF THE MODIFICATION
This Special 510(k) is being submitted to add a new 500-mL disposable canister compatible with the Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump. The modification does not affect the device's indications for use, operating principles, or energy delivery. The canister functions identically to existing cleared canisters, differing only in volume capacity and minor dimensional attributes.
## COMPARISON WITH PREDICATE DEVICE:
The subject devices is identical to the predicate device with respect to design, materials of construction, technological characteristics, performance, safety features, and intended use. The only difference is updated labeling identifying the Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump. The Nisus NPWT Canister 500-mL (CPC-500) remain unchanged from the legally marketed predicate device.
| Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(5)] | | | |
| --- | --- | --- | --- |
| Characteristic | Predicate Device Nisus One (K243187) | Subject Device(s) Cork NPWT System/Nisus Touch NPWT Pump | Comparison |
| Manufacturer | Cork Medical | Cork Medical | Same |
| Device Type | NPWT System with compatible fluid canister | NPWT Systems with the same compatible fluid canister | Equivalent (same functional family) |
| Trade Name | Nisus One (K243187) | Cork NPWT System (K140022) Nisus Touch Negative Pressure Wound Therapy Pump (K203693) | Equivalent (same functional family) |
| Regulatory Classification | Class II, Product Code: OMP (Negative Pressure Wound Therapy) | Same | Same |
| Intended Use | The canister is intended to collect wound exudate during NPWT therapy when used in conjunction with the Nisus NPWT System. | Identical intended use | Same |
| Indications for Use | The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management. The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) The Nisus ONE Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility | 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) | Equivalent |
{6}
K261291
| Summary of the technological characteristics of the device compared to the predicate device [21 CFR 807.92(a)(5)] | | | |
| --- | --- | --- | --- |
| Characteristic | Predicate Device Nisus One (K243187) | Subject Device(s) Cork NPWT System/Nisus Touch NPWT Pump | Comparison |
| | and home use environment. | The systems consist of a negative pressure wound therapy unit, dressings, tubing, and disposable canisters, including available canister configurations up to 500-mL capacity. | |
| Compatibility | Nisus One NPWT System | Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump | Equivalent (verified) |
| Technological Characteristics | Electric vacuum pump delivering controlled negative pressure | Same operating principle, pump technology, and control methods | Same |
| Use of Canister | Uses a passive, non-powered canister for fluid collection | Uses the same passive canister with no modifications | Same |
| Operating Principle | Disposable single use 500-mL canister designed for use in conjunction with a sterile dressing system and a therapy unit | Same | Identical |
| Mechanical Interface with Canister | Defined connector geometry and latch system | Same geometric interface; validated for equivalence | Equivalent |
| Materials (Canister) | Medical-grade polymer canister housing, seals, hydrophobic filter | Same | Identical |
| Electrical Components | Powered pump; canister non-electrical | Powered pump; canister non-electrical | Same |
| Thermal Characteristics | No heat generation from canister; pump meets IEC 60601-1 electrical safety (applicable under original clearance) | Same; canister introduces no thermal risk | Same |
| Performance | Vacuum integrity and leak resistance established | Verification testing confirms equivalence | Equivalent |
| Biocompatibility (Canister) | The canister does not have direct or indirect patient contact | Same | Same |
| Sterility | Non-Sterile | Same | Same |
| Shelf Life | Validated for canister and packaging | Same shelf life; no changes to packaging or materials | Same |
| Clinical Performance | Supported by prior NPWT system data | Same intended use and performance expectations | Same |
| Risk Profile | Acceptable per prior clearance | Risk unchanged; no new hazards | Same |
| Conclusion | Legally marketed NPWT system and canister | Performs equivalently with identical canister; no new safety or performance concerns | Substantially Equivalent |
Page 3 of 4
{7}
K261291
# NONCLINICAL TESTS
The Nisus NPWT Canister 500-mL (CPC-500) underwent bench verification testing to confirm basic functionality and performance when used with the Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump. Testing was conducted using simulated wound exudate under representative operating conditions.
The following bench performance testing were performed:
- Leak Alarm Testing
- Block Alarm Testing
- Canister Full Alarm Testing
- 3-Day Functionality Testing
- Low Continuous Mode 40 mm-hg Testing
- High Continuous Mode 200 mm-hg Testing
- Flow rate with simulated exudate Testing
- Battery Runtime with simulated exudate Testing
Test results demonstrated that the Nisus NPWT Canister 500-mL (CPC-500) functioned as intended and met predefined acceptance criteria when used with both the Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump. No performance anomalies were observed during testing, and device functionality was consistent across all evaluated test conditions.
# CONCLUSION:
Based on the identical intended use, similar technological characteristics, and successful verification and validation testing, the Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump is substantially equivalent to the predicate device. The addition of the Nisus NPWT Canister 500-mL (CPC-500) does not raise new questions of safety or effectiveness.
Page 4 of 4
