Cleared Traditional

K120357 - ENDOSCOPE REPROCESSOR OER-MINI

K120357 is an FDA 510(k) clearance for ENDOSCOPE REPROCESSOR OER-MINI, manufactured by Olympus Medical Systems Corp.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K120357 · Olympus Medical Systems Corp. · General Hospital
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Dec 2012
Decision
318d
Days
Class 2
Risk

K120357 is an FDA 510(k) clearance for the ENDOSCOPE REPROCESSOR OER-MINI. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - 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. Elevated predicate reliance profile. 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.

View all Olympus Medical Systems Corp. devices

FDA 510(k) Submission Details - K120357

510(k) Number K120357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date December 20, 2012
Days to Decision 318 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
189d slower than avg
Panel avg: 129d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEB Device Classification - Class 2, Special Controls

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FEB Accessories, Cleaning, For Endoscope

All 32
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K120357.
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · Advanced Sterilization Products (Asp) · Apr 2019
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
EVOTECH ECR
K140977 · Advanced Sterilization Products · Dec 2014
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · Olympus Medical Systems Corporation · Feb 2011
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · Minntech Corp. · Apr 2010
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · Olympus Medical Systems Corporation · Feb 2010