Cleared Traditional

K103504 - GETINGE 400HC/500HC SERIES STEAM STERILIZER

K103504 is an FDA 510(k) clearance for GETINGE 400HC/500HC SERIES STEAM STERILIZER, manufactured by Getinge Sourcing, LLC. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K103504 · Getinge Sourcing, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
110d
Days
Class 2
Risk

K103504 is an FDA 510(k) clearance for the GETINGE 400HC/500HC SERIES STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on March 16, 2011 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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 - K103504

510(k) Number K103504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date March 16, 2011
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 153
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K103504.
AMSCO CHIMERON MEDIUM STEAM STERILIZER
K112055 · STERIS Corporation · Dec 2011
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
K111736 · Tuttnauer Co. , Ltd. · Dec 2011
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · STERIS Corporation · Sep 2011
BELIMED STEAM STERILIZER MST-V
K103841 · Sauter AG · Mar 2011
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
K100622 · Belimed Sauter AG · Aug 2010
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
K093333 · Primus Sterilizer Company, LLC · Apr 2010