Regulatory topic
FDA 510(k) clearances, searchable and monitored
A 510(k) is the FDA premarket notification most Class II devices need before US sale. MedTech Signal imports every published 510(k) decision from openFDA and links each record to the FDA database entry.
What a 510(k) is
A 510(k) demonstrates that a device is substantially equivalent to a legally marketed predicate device. The FDA publishes the decision, applicant, product code and decision date, and usually a summary document.
What you can do in MedTech Signal
Search clearances by device name or manufacturer with normalized company names, compare US clearances with Health Canada licences, see submission summaries, and receive alerts when a watched company receives a new clearance.
Why cross-border context matters
A device cleared in the US may or may not be licensed in Canada. MedTech Signal shows matches as Matched, Possible match or No apparent match — never as proof a device is unlicensed.
Software in a device, and software as a device
Many 510(k) clearances are for software — embedded in hardware or standalone (SaMD). You can search clearances in software-heavy product codes, read the decision summaries of AI-enabled devices, and track the software lifecycle standards (IEC 62304, ISO 14971) those submissions rely on.
Source: FDA openFDA 510(k) dataset, refreshed on a schedule. De Novo and PMA decisions are also held.