DeviceClearance

Infinity® Acute Care System (IACS) VG8.1— 510(k) K260579

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K260579 for Infinity® Acute Care System (IACS) VG8.1, Substantially Equivalent on 2026-08-20. Applicant: Draeger Medical Systems, Inc.. Device class: 2.

Summary

Draeger Medical Systems filed the Infinity Acute Care System (IACS) VG8.1 under product code MHX, physiological patient monitors with arrhythmia detection or alarms. The record doesn't say what VG8.1 refers to.

Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).

Draeger filed from Andover, Massachusetts. The substantially equivalent decision came 181 calendar days after receipt (February 20 to August 20, 2026).

Clearance details

Applicant
Draeger Medical Systems, Inc.
Product code
Product code MHX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Andover, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.