Cleared Traditional

K153713 - Getinge Series Warming Cabinet

K153713 is an FDA 510(k) clearance for Getinge Series Warming Cabinet, manufactured by Getinge Sourcing, LLC. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K153713 · Getinge Sourcing, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
166d
Days
Class 1
Risk

K153713 is an FDA 510(k) clearance for the Getinge Series Warming Cabinet. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on June 7, 2016 after a review of 166 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5950 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153713

510(k) Number K153713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2015
Decision Date June 07, 2016
Days to Decision 166 days
Submission Type Traditional
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
37d slower than avg
Panel avg: 129d · This submission: 166d
Pathway characteristics
Predicate-based equivalence.

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 19
Devices cleared under the same product code (LHC) and FDA review panel - the closest regulatory comparables to K153713.
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
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
K142080 · Ecolab, Inc. · Aug 2014
INTRATEMP SOLUTION WARMER
K083417 · C Change Surgical, LLC · Jan 2009
SWC/DWC WARMING CABINETS
K080609 · Mac Medical · Jun 2008