Cleared Special

K110769 - AMSCO WARMING CABINET

K110769 is the FDA 510(k) clearance for AMSCO WARMING CABINET by STERIS Corporation. It is a Class 2 General Hospital device (product code LGZ) cleared through the Special 510(k) pathway after a 77-day FDA review.

K110769 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
77d
Days
Class 2
Risk

K110769 is an FDA 510(k) clearance for the AMSCO WARMING CABINET. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 3, 2011 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K110769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2011
Decision Date June 03, 2011
Days to Decision 77 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 17
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K110769.
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080 · Smiths Medical Asd, Inc. · Jun 2008
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001