Cleared Traditional

K112702 - IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS

K112702 is an FDA 510(k) clearance for IMPERIAL SURGICAL LTD. BLANKEY AND SOLU..., manufactured by Imperial Surgical , Ltd.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K112702 · Imperial Surgical , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
195d
Days
Class 2
Risk

K112702 is an FDA 510(k) clearance for the IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Imperial Surgical , Ltd. (Dundas, CA). The FDA issued a Cleared decision on March 29, 2012 after a review of 195 days - an extended review cycle.

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.

View all Imperial Surgical , Ltd. devices

FDA 510(k) Submission Details - K112702

510(k) Number K112702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2011
Decision Date March 29, 2012
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
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 26
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K112702.
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
ENTERAL NUTRITION WARMER
K122449 · Acacia, Inc. · Jun 2013
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011