510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K110769Substantially Equivalent

Amsco Warming Cabinet

STERIS Corporation, Mentor OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110769 is the FDA 510(k) clearance record for AMSCO WARMING CABINET, a class II device, cleared for STERIS Corporation on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K110769.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5960 Heisley, Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LGZ

Trailing 12 months
2 clearances under product code LGZ in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260