Cleared Traditional

C CHANGE SOLUTION WARMER (K051819) - FDA 510(k) Clearance

Class I General Hospital device.

K051819 · C Change Surgical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
41d
Days
Class 1
Risk

K051819 is an FDA 510(k) clearance for the C CHANGE 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 August 15, 2005 after a review of 41 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.

View all C Change Surgical, LLC devices

Submission Details

510(k) Number K051819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date August 15, 2005
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.