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The Tracker / October 2026 / K252736

510(k) cleared

Hemotag Analysis Software (HAS)

Aventusoft, LLC · Oct 21, 2026 · K252736

FDA cleared the Hemotag Analysis Software (HAS) from Aventusoft, LLC on Oct 21, 2026 under K252736, a traditional 510(k). The device falls under product code DQD, Stethoscope, Electronic, regulated at 21 CFR 870.1875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 28, 2025. The decision came 419 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Aventusoft, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252736?

K252736 is the FDA 510(k) for Hemotag Analysis Software (HAS), submitted by Aventusoft, LLC. FDA's decision date was Oct 21, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the Hemotag Analysis Software (HAS)?

Aventusoft, LLC, based in Boca Raton, FL, is the applicant of record for K252736.

How long did the K252736 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Oct 21, 2026, 419 days later.

← All decisions in October 2026