Cleared Traditional

K261694 - CORE 300 Digital Stethoscope

K261694 is an FDA 510(k) clearance for CORE 300 Digital Stethoscope, manufactured by Eko Health, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K261694 · Eko Health, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
62d
Days
Class 2
Risk

K261694 is an FDA 510(k) clearance for the CORE 300 Digital Stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on July 23, 2026 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eko Health, Inc. devices

FDA 510(k) Submission Details - K261694

510(k) Number K261694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2026
Decision Date July 23, 2026
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 59
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K261694.
AiSteth®
K252915 · Ai Health Highway India Pvt., Ltd. · May 2026
Tyto Stethoscope (G3)
K252089 · Tyto Care , Ltd. · Mar 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · Kneevoice, Inc. · Feb 2026
eMurmur Heart AI
K252284 · Csd Labs · Dec 2025
Stethophone Pro
K252595 · Sparrow Acoustics, Inc. · Sep 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · Eko Health, Inc. · Aug 2025