Cleared Traditional

K142173 - NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (FDA 510(k) Clearance)

Class I General Hospital device.

K142173 · Ecolab, Inc. · General Hospital
Dec 2014
Decision
145d
Days
Class 1
Risk

K142173 is an FDA 510(k) clearance for the NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Ecolab, Inc. (Saint Paul, US). The FDA issued a Cleared decision on December 30, 2014 after a review of 145 days - within the typical 510(k) review window.

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: 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.

Submission Details

510(k) Number K142173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2014
Decision Date December 30, 2014
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 169d · This submission: 145d
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.