Cleared Traditional

K092823 - AMSCO WARMING CABINET

K092823 is an FDA 510(k) clearance for AMSCO WARMING CABINET, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K092823 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
95d
Days
Class 2
Risk

K092823 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 December 18, 2009 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092823

510(k) Number K092823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date December 18, 2009
Days to Decision 95 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K092823.
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · Emit Corporation · May 2011
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
K091336 · Enthermics Medical Systems, Inc. · May 2010
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
K092366 · Thermal Therapeutic Systems, Inc. · Mar 2010
BELMONT HYPERTHERMIA PUMP
K090089 · Belmont Instrument Corp. · Feb 2009
ASTOFLO PLUS
K082765 · Stihler Electronic GmbH · Dec 2008
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217 · Arizant Healthcare, Inc. · Oct 2008
K092823 · AMSCO WARMING CABINET
Download PDF FDA Summary STERIS Corporation