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Cipher is pleased to announce the launch of a new integration supporting 510(k) premarket notifications on the Knowledge360Ⓡ platform. We’re passionate about constantly improving Knowledge360 to better serve the needs of our users, and we’re confident this new integration will deliver significant value for organizations following the development of medical devices. 

Knowledge360 users now have the ability to search for 510(k) Premarket Notifications, add alerts on competitor approvals, and incorporate 510(k) information into real-time dashboards. As soon as a new 510(k) is issued by the FDA, Knowledge360 users will be the first to know, unlocking high-value competitive insights and significantly augmenting the work of their Marketing and Competitive Intelligence (M/CI) function.

510(k) Premarket Notifications: A Brief Overview

The vast majority of Class II medical devices brought to market in the U.S. require the submission and approval of a 510(k) Premarket Notification, issued by the FDA. Class II devices are characterized as “immediate risk products”, and examples include devices like catheters or pregnancy tests. The purpose of the 510(k) is to demonstrate that a new device is “substantially equivalent” to another device currently in commercial distribution, and therefore does not require extensive clinical trials that are mandated for newer, more innovative devices. 

Medical device manufacturers must submit a 510(k) when they have significantly updated the technology used in the device, or want to change the intended use of the device. These submissions contain a wealth of information, and represent a huge source of competitive intelligence for competing medical device companies. 

Information included in submissions includes the devices named as predicates, the materials the device is made of, and details of the bench tests the device was submitted to. For many M/CI practitioners in the medical device industry, 510(k) Premarket Notifications represent one of the foremost sources of meaningful competitive intelligence. 

Until now, all of this information has only existed in the FDA’s online databases and is available only as a scattered collection of letters and documents that are difficult to search, challenging to categorize, and time-consuming to navigate.

Introducing 510(k) Premarket Notifications in Knowledge360

Knowledge360 now pulls information on 510(k) Premarket Notifications daily, and offers users a variety of tools to effectively manage how their organization utilizes this data.

All 510(k) Premarket Notifications are fully searchable in Knowledge360. Users can search using a variety of criteria: from the name of their competitor to the device classification the product was approved under. Having discovered relevant 510(k) approvals, users can access full documentation, including approval notices and summary letters. 


Knowledge360 users can also set up custom alerts, so that as soon as a relevant 510(k) is issued, they’ll be the first to know. These alerts can be set up for particular competitors, device groups, or using a range of other filters. 

Real-time information on 510(k) approvals can also be added to Knowledge360 dashboards, serving to create a more comprehensive competitive or market overview that ensures everyone in the organization has the latest competitive insights at their fingertips. 

Unlocking Value from Real-Time 510(k) Premarket Notifications

Studies have shown that, on average, medical device organizations only have two employees responsible for M/CI initiatives. Clearly, it’s unrealistic to expect such a small team to stay up-to-date with all the latest developments, if they are reliant on manual processes to do so. 

The information contained in 510(k) Premarket Notifications represents a goldmine of competitive intelligence, and the ability to access this without friction significantly streamlines the workflows of competitive intelligence practitioners in the medical devices industry. 

Previously, searching for this information required a significant time investment by M/CI professionals, and manually searching for information made it likely that delays occurred between identifying and reporting key insights.

In addition, the kind of information that can be gained from immediate knowledge of 510(k) approvals is something that is never readily available on a competitor website. By the time information about the new product arrives on a competitor website, it will be too late for your organization to do much about it. This new integration means that M/CI professionals can be alerted to new developments as soon as humanly possible, and share information across their organization with just a few clicks. 

With the addition of 510(k) data, Knowledge360 also adds a new layer of context to competitive intelligence. Dashboards containing 510(k) information and alerts can be built for each competitor, or for specific device classifications. To enhance 510(k) insights, these dashboards can also be built to contain a trove of information, including news and press, financial performance, and information on key competitive indicators like hiring patterns. 

Using Knowledge360 for CI in the Medical Device Industry

This update represents a major improvement in the value of Knowledge360 for M/CI practitioners in the medical device field. 

The ability to monitor and analyze 510(k) Premarket Approvals perfectly complements existing features the team at Cipher has custom-developed for medical device companies. These include the monitoring of a competitor's clinical trials, or the ability to track information like investments, key leadership hires, and other indicators of a shift in a competitor’s strategy. 

In embracing a true intelligence hub like Knowledge360, medical device organizations can significantly improve the efficacy of their M/CI function and reliably deliver high-impact insights to the leadership of their organization. 

To learn more about Knowledge360 for medical device companies, schedule a demo today. 

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