Cleared Special

K142080 - NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED (FDA 510(k) Clearance)

Class I General Hospital device.

K142080 · Ecolab, Inc. · General Hospital
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
141d faster than avg
Panel avg: 169d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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.