Cleared Special

K150190 - IntraTemp Solution Warmer (FDA 510(k) Clearance)

Class I General Hospital device.

K150190 · Ecolab, Inc. · General Hospital
Feb 2015
Decision
30d
Days
Class 1
Risk

K150190 is an FDA 510(k) clearance for the IntraTemp Solution Warmer. 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 February 26, 2015 after a review of 30 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 K150190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date February 26, 2015
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 169d · This submission: 30d
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.