Cleared Traditional

K083417 - INTRATEMP SOLUTION WARMER

K083417 is an FDA 510(k) clearance for INTRATEMP SOLUTION WARMER, manufactured by C Change Surgical, LLC. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K083417 · C Change Surgical, LLC · General Hospital
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Jan 2009
Decision
56d
Days
Class 1
Risk

K083417 is an FDA 510(k) clearance for the INTRATEMP SOLUTION WARMER. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by C Change Surgical, LLC (Winston-Salem, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5950 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K083417

510(k) Number K083417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2008
Decision Date January 13, 2009
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

LHC Device Classification - Class 1, General Controls

Product Code LHC Warmer, Irrigation Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LHC Warmer, Irrigation Solution

All 23
Devices cleared under the same product code (LHC) and FDA review panel - the closest regulatory comparables to K083417.
IntraTemp Solution Warmer
K150190 · Ecolab, Inc. · Feb 2015
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173 · Ecolab, Inc. · Dec 2014
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
K142080 · Ecolab, Inc. · Aug 2014
SWC/DWC WARMING CABINETS
K080609 · Mac Medical · Jun 2008
C CHANGE SOLUTION WARMER
K051819 · C Change Surgical, LLC · Aug 2005
ORS-3000LD
K023282 · O.R. Solutions, Inc. · Nov 2002
K083417 · INTRATEMP SOLUTION WARMER
Download PDF C Change Surgical, LLC