Cleared Traditional

K973748 - TEMPO AND TEMP H20

K973748 is an FDA 510(k) clearance for TEMPO AND TEMP H20, manufactured by Smith. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K973748 · Smith · General Hospital
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Mar 1998
Decision
160d
Days
Class 2
Risk

K973748 is an FDA 510(k) clearance for the TEMPO AND TEMP H20. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Smith (Crofton, US). The FDA issued a Cleared decision on March 10, 1998 after a review of 160 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 Smith devices

FDA 510(k) Submission Details - K973748

510(k) Number K973748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1997
Decision Date March 10, 1998
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
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 19
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K973748.
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
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982