[ LIVE INTELLIGENCE · DEVICE MARKET ENTRY ]
What’s entering the US device market
A current public snapshot of FDA 510(k) clearances and PMA approvals. SPEQ Intelligence analysis adds the complete pathway mix, specialty concentration, monthly cadence, current decisions, and evidence-planning prompts.
FDA device decisions are posted on a lag. Clearance and approval are different evidentiary pathways, not a quality ranking or FDA endorsement.
PUBLIC SNAPSHOT
A pathway, specialty, and cadence view of FDA 510(k) clearances and original PMA approvals.
11,853Decisions tracked
57%510(k) pathway share
Helo Return · 2026-10-11 · 510K · K253717
TruVision Single-Use 1.9mm Arthroscopy System · 2026-10-09 · 510K · K260156
IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) · 2026-10-09 · 510K · K262352