Cleared Traditional

K120357 - ENDOSCOPE REPROCESSOR OER-MINI

K120357 is the FDA 510(k) clearance for ENDOSCOPE REPROCESSOR OER-MINI by Olympus Medical Systems Corp.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 17
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K120357.
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · Olympus Medical Systems Corp. · Jul 2019
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
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · Olympus Medical Systems Corporation · Feb 2011
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · Olympus Medical Systems Corporation · Feb 2010
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001