Cleared Traditional

K092366 - TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE

K092366 is an FDA 510(k) clearance for TTS100 PORTABLE HYPERTHERMIC PERFUSION ..., manufactured by Thermal Therapeutic Systems, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K092366 · Thermal Therapeutic Systems, Inc. · General Hospital
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Mar 2010
Decision
211d
Days
Class 2
Risk

K092366 is an FDA 510(k) clearance for the TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Thermal Therapeutic Systems, Inc. (Moon Township, US). The FDA issued a Cleared decision on March 4, 2010 after a review of 211 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 Thermal Therapeutic Systems, Inc. devices

FDA 510(k) Submission Details - K092366

510(k) Number K092366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date March 04, 2010
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 29
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K092366.
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
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
BELMONT HYPERTHERMIA PUMP
K090089 · Belmont Instrument Corp. · Feb 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