On Friday, FDA codified a brand-new device classification: the diabetes digital behavioral therapeutic, 21 CFR 880.5735. That makes 13 digital-behavioral-therapeutic lanes FDA maintains. Here is every 510(k) that has ever driven through any of them.
Each row is one FDA product code — a classification regulation a builder can cite as a predicate lane. Each dot is one follow-on 510(k) clearance riding that lane, placed by decision year. Hover any dot for the company and FDA review time.
A lane is not a market. Each of these classifications was born from a De Novo grant — and a De Novo is not a 510(k), so the original pioneering device (reSET, EndeavorRx, BT-001…) is not a dot here. What the dots measure is exactly what a predicate lane is for: follow-on clearances. By that measure, the lanes are nearly empty.
Empty may mean "unpaid," not "impossible." The diabetes lane's special controls demand clinical data and four limiting label statements — that's the regulatory toll. But as today's newsletter argues, the lane most builders actually stall in is payment: coverage is permission to bill; it isn't the money. FDA opened the lane Friday. Nobody has priced the traffic.
Small numbers, loud stories. With 15 clearances total, one active company (a Pear, a Big Health, an AppliedVR) can look like a "trend." It's one car changing lanes.