Cleared Traditional

Kneevoice Cartilage Evaluation System (750-3600-001)

K252076 · Kneevoice, Inc. · Cardiovascular
Feb 2026
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K252076 is an FDA 510(k) clearance for the Kneevoice Cartilage Evaluation System (750-3600-001), a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Kneevoice, Inc. (Santa Monica, US). The FDA issued a Cleared decision on February 6, 2026, 219 days after receiving the submission on July 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K252076 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date February 06, 2026
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQD — Stethoscope, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1875