Cleared Traditional

K261494 - Smart Wireless Stethoscope (STEMO310)

Also marketed or referenced as:
Smart Wireless Stethoscope (STEMO710) Smart Wireless Stethoscope (STEMO720) Smart Wireless Stethoscope (STEMO730)

K261494 is an FDA 510(k) clearance for Smart Wireless Stethoscope (STEMO310), manufactured by Shanghai Hulu Devices Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K261494 · Shanghai Hulu Devices Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
86d
Days
Class 2
Risk

K261494 is an FDA 510(k) clearance for the Smart Wireless Stethoscope (STEMO310). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Shanghai Hulu Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 31, 2026 after a review of 86 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 Shanghai Hulu Devices Co., Ltd. devices

FDA 510(k) Submission Details - K261494

510(k) Number K261494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2026
Decision Date July 31, 2026
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 K261494.
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