Cleared Traditional

K122625 - GETINGE 800HC- SERIES STEAM STERILIZER

K122625 is an FDA 510(k) clearance for GETINGE 800HC- 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 267-day FDA review.

K122625 · Getinge Sourcing, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
267d
Days
Class 2
Risk

K122625 is an FDA 510(k) clearance for the GETINGE 800HC- 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 May 22, 2013 after a review of 267 days - an extended review cycle.

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 - K122625

510(k) Number K122625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date May 22, 2013
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
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 K122625.
SAKURA STEAM STERILIZER ASSR
K132439 · Sakura Seiki Co., Ltd. · Jan 2014
BELIMED STEAM STERILIZER MST-V
K130172 · Belimed, Inc. · Sep 2013
SANICLAVE 102, MODEL RS-SC-102
K122978 · Alternative Pioneering Research and Development · May 2013
SAKURA STEAM STERILIZAER MODEL ASSV-AH06
K122774 · Sakura Seiki Co., Ltd. · May 2013
GETINGE 400HC-E / SERIES STEAM STERILIZER
K122071 · Getinge Sourcing, LLC · Mar 2013
STATIM 2000 G4 CASSETTE
K112872 · Scican , Ltd. · Jul 2012