Cleared Special

K150190 - IntraTemp Solution Warmer

K150190 is an FDA 510(k) clearance for IntraTemp Solution Warmer, 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 30-day FDA review.

K150190 · Ecolab, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Ecolab, Inc. devices

FDA 510(k) Submission Details - K150190

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
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 K150190.
Getinge Series Warming Cabinet
K153713 · Getinge Sourcing, LLC · Jun 2016
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
K152522 · Ecolab, Inc. · Jan 2016
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173 · Ecolab, Inc. · Dec 2014
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