Cleared Traditional

Eko Foundation Analysis Software with Transformers (EFAST)

K251494 · Eko Health, Inc. · Cardiovascular
Aug 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K251494 is an FDA 510(k) clearance for the Eko Foundation Analysis Software with Transformers (EFAST), a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on August 12, 2025, 89 days after receiving the submission on May 15, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K251494 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2025
Decision Date August 12, 2025
Days to Decision 89 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