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The Tracker / August 2026 / K260604

510(k) cleared

BiWaze Clear System

Abmrc, LLC · Aug 24, 2026 · K260604

FDA cleared the BiWaze Clear System from Abmrc, LLC on Aug 24, 2026 under K260604, a traditional 510(k). The device falls under product code NHJ, Device, Positive Pressure Breathing, Intermittent, regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Feb 24, 2026. The decision came 181 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 Abmrc, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260604?

K260604 is the FDA 510(k) for BiWaze Clear System, submitted by Abmrc, LLC. FDA's decision date was Aug 24, 2026, under product code NHJ (Device, Positive Pressure Breathing, Intermittent).

Who makes the BiWaze Clear System?

Abmrc, LLC, based in Eagan, MN, is the applicant of record for K260604.

How long did the K260604 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Aug 24, 2026, 181 days later.

← All decisions in August 2026