Cleared Special

K152522 - ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (FDA 510(k) Clearance)

Class I General Hospital device.

K152522 · Ecolab, Inc. · General Hospital
Jan 2016
Decision
134d
Days
Class 1
Risk

K152522 is an FDA 510(k) clearance for the ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes. 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 January 15, 2016 after a review of 134 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. 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. Standard predicate reliance. 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 K152522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date January 15, 2016
Days to Decision 134 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 169d · This submission: 134d
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.