Nisus One Secures FDA Clearance: A Milestone in Innovation and Teamwork

The Nisus One is Cork Medical’s latest advancement in Negative Pressure Wound Therapy (NPWT), a device designed to deliver the same powerful healing outcomes clinicians expect from our Nisus platform, but with greater simplicity, mobility, and affordability.

Bringing this device to market was no small feat. This achievement represents the culmination of a five-year journey through an extensive FDA clearance process, requiring rigorous testing, detailed documentation, and cross-functional collaboration at every stage.

Let’s dive into what makes the Nisus One stand out in the NPWT market, share insights into the five-year FDA clearance journey, highlight the teams that made this milestone possible, and understand what impact this has on Cork Medical’s innovative drive forward.

Get to Know the Nisus One

The Nisus One is uniquely positioned to combine high-performance therapy and ease of use with cost-conscious design and reliability. By eliminating the complexity that comes with traditional NPWT systems, the Nisus One’s intuitive plug-and-play design and one-button operation addresses some of the biggest challenges faced in post-acute care.

• Simplifying NPWT Treatment

  • With minimal training required and an intuitive setup, the Nisus One reduces clinical downtime.

• Lowering Cost while Maintaining Performance

  • Built with the same technology and clinical outcomes as our other NPWT devices, the Nisus One grants access to NPWT at a more accessible price point.

• Creating Patient-Friendly Experiences

  • The compact design creates greater mobility and comfort for patients in any care setting.

• Maintaining Compatibility with Other NPWT Devices

  • Its compatibility with our existing Nisus accessories makes for a seamless integration.

Understanding the FDA Clearance Process

Before any medical device can be marketed in the U.S., the FDA requires proof that the product is safe, effective, and comparable to an existing legally marketed device. However, earning clearance isn’t just about submitting paperwork, it’s a comprehensive process that spans design, testing, and validation.

To complete the submission process, the FDA requires our team to provide the following information:

• A detailed description of the device, including specs, diagrams, and operational principles

• Clinical indications for use and patient population details

• A comparison to an existing legally marketed device, showing substantial equivalence

• Extensive performance testing, including electrical safety, usability, alarm functionality, and suction performance

• Software validation

• Sterilization and shelf-life data

• Conduct a full risk analysis under ISO 14971

• Complete labeling and instructions for use to meet FDA and UDI (Unique Device Identifier) compliance

After submitting this information, we file for what’s called a 510(k) clearance—the standard clearance pathway for Class II medical devices. Given the Nisus One was built under the Class II medical device category, this process was the most critical for us because it ensured the Nisus One would meet strict regulatory and patient safety standards prior to being marketed.

While it seems like the submission process is straightforward, we encountered a lot of challenges along the way. One of the biggest challenges was adapting to new FDA requirements around usability and end-user risk assessment.

This shift impacted both our regulatory strategy and NPWT pump design timeline because this new requirement was introduced mid-development. For us to remain FDA compliant, we had to implement better usability protocols, like the alarm functionality and suction performance.

Thanks to strong project management and cross-functional collaboration, we met these new standards without delaying submission.

Behind the Clearance: The Teams That Made It Possible

Bringing the Nisus One through FDA clearance required cross-functional collaboration and the expertise of our Regulatory Affairs, Research & Development, and Engineering teams.

From the start, these teams worked together to interpret evolving FDA requirements and embed them into our design process. By aligning early on risk assessment strategies and usability testing protocols, the team avoided costly rework and proactively addressed critical elements like alarm functionality and suction performance.

While this was truly a team effort, the leadership and technical contributions of Clinical Engineer Matt Cranfill, Quality Engineer Antonio Williams, and Engineering Manager Jim Smock were instrumental in guiding the project from concept through submission. They maintained consistent communication, were transparent with timelines, and allowed joint decision-making to keep the project agile and on track.

This level of teamwork exemplifies Cork Medical’s ability to adapt, innovate, and deliver.

Bringing Nisus One to Market: The Impact on Cork Medical’s Success

The FDA clearance of the Nisus One marks Cork Medical’s sixth successful 510(k) submission, a milestone that strengthens our position as a trusted leader in wound care innovation.

For clinicians, this approval reinforces confidence in our products, assuring them that every device meets the highest safety and performance standards. For distributors, it elevates our credibility and marketability, making Cork Medical an even stronger choice for expanding partnerships and adoption. For regulators, it demonstrates our unwavering commitment to compliance, quality, and alignment with evolving FDA expectations.

Each clearance builds on the one before it, showcasing our ability to deliver safe, effective, and user-focused medical devices, while upholding the regulatory excellence that defines Cork Medical.

What’s Next for Cork Medical?

The launch of the Nisus One is only the beginning. Cork Medical has strategic plans to continue expanding and enhancing our NPWT portfolio, focusing on both core device innovation and complementary accessories, such as PVA Foam.

These efforts are driven by a clear mission: to improve clinical outcomes and expand NPWT use cases across multiple care settings. By investing in technology that prioritizes patient needs and provider efficiency, Cork Medical will continue to strengthen its position as a leader in advanced wound care solutions.