Cleared Traditional

K252736 - Hemotag Analysis Software (HAS)

K252736 is an FDA 510(k) clearance for Hemotag Analysis Software (HAS), manufactured by Aventusoft, LLC. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K252736 · Aventusoft, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
419d
Days
Class 2
Risk

K252736 is an FDA 510(k) clearance for the Hemotag Analysis Software (HAS). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Aventusoft, LLC (Boca Raton, US). The FDA issued a Cleared decision on October 21, 2026 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K252736

510(k) Number K252736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2025
Decision Date October 21, 2026
Days to Decision 419 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
294d slower than avg
Panel avg: 125d · This submission: 419d
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 156
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K252736.
Smart Wireless Stethoscope (STEMO310)
K261494 · Shanghai Hulu Devices Co., Ltd. · Jul 2026
CORE 300 Digital Stethoscope
K261694 · Eko Health, Inc. · Jul 2026
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
K252736 · Hemotag Analysis Software (HAS)
Download PDF FDA Summary Aventusoft, LLC