Cleared Traditional

K142173 - NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE

K142173 is an FDA 510(k) clearance for NON-STERILE ORS-400N SCOPE PILLOW WARME..., manufactured by Ecolab, Inc.. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K142173 · Ecolab, Inc. · General Hospital
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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.

View all Ecolab, Inc. devices

FDA 510(k) Submission Details - K142173

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
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 13
Devices cleared under the same product code (LHC) and FDA review panel - the closest regulatory comparables to K142173.
Getinge Series Warming Cabinet
K153713 · Getinge Sourcing, LLC · Jun 2016
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
K152522 · Ecolab, Inc. · Jan 2016
IntraTemp Solution Warmer
K150190 · Ecolab, Inc. · Feb 2015
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