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The Tracker / August 2026 / K260579

510(k) cleared

Infinity® Acute Care System (IACS) VG8.1

Draeger Medical Systems, Inc. · Aug 20, 2026 · K260579

FDA cleared the Infinity® Acute Care System (IACS) VG8.1 from Draeger Medical Systems, Inc. on Aug 20, 2026 under K260579, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 20, 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 Draeger Medical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260579?

K260579 is the FDA 510(k) for Infinity® Acute Care System (IACS) VG8.1, submitted by Draeger Medical Systems, Inc.. FDA's decision date was Aug 20, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Infinity® Acute Care System (IACS) VG8.1?

Draeger Medical Systems, Inc., based in Andover, MA, is the applicant of record for K260579.

How long did the K260579 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Aug 20, 2026, 181 days later.

← All decisions in August 2026