FDA 510(k) clearance · back to tracker
Infinity® Acute Care System (IACS) VG8.1
Draeger Medical Systems, Inc. cleared K260579 on 2026-08-20, decision: substantially equivalent
K-number
K260579
Sponsor
Draeger Medical Systems, Inc.
Device
Infinity® Acute Care System (IACS) VG8.1
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-08-20
Product code
MHX
Advisory committee
Cardiovascular
Medical specialty
Cardiovascular
Regulation number
870.1025
Official FDA record
Open K260579on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Drop K260579 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.