FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976-2025.

Abstract

We characterized regulatory and safety patterns of FDA 510(k)-cleared chronic pain devices over five decades. We analyzed 1718 chronic pain devices cleared from 1976-2025, assessing device modality, review times, recalls (2002-2025), and market concentration (Herfindahl - Hirschman Index, HHI). Most devices were noninvasive neuromodulation (1,486 [86.5%]), followed by invasive neuromodulation (162 [9.4%]), energy-based (67 [3.9%]), and digital therapeutics (3 [0.2%]). Median FDA review was 117 d