Cleared Special

K142080 - NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED

K142080 is an FDA 510(k) clearance for NON-STERILE ORS WARNING DRAPES/SLUSH+WA..., manufactured by Ecolab, Inc.. The device is a Class 1 General Hospital device with product code LHC cleared through the Special 510(k) pathway after a 28-day FDA review.

K142080 · Ecolab, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2014
Decision
28d
Days
Class 1
Risk

K142080 is an FDA 510(k) clearance for the NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRA.... 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 August 28, 2014 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ecolab, Inc. devices

FDA 510(k) Submission Details - K142080

510(k) Number K142080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2014
Decision Date August 28, 2014
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K142080.
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-400N SCOPE PILLOW WARMER DRAPE
K142173 · Ecolab, Inc. · Dec 2014
SWC/DWC WARMING CABINETS
K080609 · Mac Medical · Jun 2008
C CHANGE SOLUTION WARMER
K051819 · C Change Surgical, LLC · Aug 2005
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136 · Princeton Regulatory Assoc. · Oct 1998