Cleared Traditional

CARA System

K252500 · Cara Medical, Ltd. · Radiology

Feb 2026

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K252500 is an FDA 510(k) clearance for the CARA System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Cara Medical, Ltd. (Rd. Town, VG). The FDA issued a Cleared decision on February 20, 2026, 196 days after receiving the submission on August 8, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K252500 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2025
Decision Date	February 20, 2026
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy