Find here all our blog posts tagged with: 510(k).

Aerial view of a river dividing into a wide shallow channel and a narrow deep channel at a stone weir.

The Real AI Device Risk Is Where FDA Doesn't Look Closely

Most AI-enabled devices clear FDA through the least rigorous pathway or avoid device classification entirely, leaving agentic AI's failure modes unexamined.

Abstract image of a heartbeat waveform merging with pharmacy shelves to represent AI moving from device clearance into clinical practice.

Device Clearance Outpaces Practice Governance

Tempus's third FDA-cleared AI-ECG tool shows the 510(k) pathway working smoothly, while new pharmacy guidance reveals governance gaps at the point of use.

An abstract electrocardiogram waveform branching into three glowing paths, symbolizing one AI platform expanding across multiple cleared indications.

The Platform Risk Hiding in Serial Clearances

Tempus AI's third ECG-based FDA clearance shows how one platform can accrete indications faster than buyers can verify its cumulative risk profile.