AMSCO WARMING CABINET— 510(k) K111870

Name: FDA 510(k) clearance K111870
Creator: U.S. Food and Drug Administration
Published: 2011-07-29

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K111870 for AMSCO WARMING CABINET, Substantially Equivalent on 2011-07-29. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2011-07-01
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K111870

K-number listed on FDA's recall record

Z-0603-2016 — AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.Class II·Terminated·Steris Corporation·20151120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111870.

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