Quantum Blood and Fluid Warming System— 510(k) K192325

Name: FDA 510(k) clearance K192325
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Substantially Equivalent

Life Warmer, Inc.

FDA 510(k) clearance K192325 for Quantum Blood and Fluid Warming System, Substantially Equivalent on 2019-10-18. Applicant: Life Warmer, Inc.. Device class: 2.

Clearance details

Applicant: Life Warmer, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2019-08-27
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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K181775 — Quantum Blood and IV Fluid Infusion Warmer2019-01-28

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.