Cleared Special

EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082392 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
86d
Days
Class 2
Risk

K082392 is an FDA 510(k) clearance for the EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Sterilization Products devices

Submission Details

510(k) Number K082392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date November 13, 2008
Days to Decision 86 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 56
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K082392.
System 83 Revolve Endoscope Washer/Disinfector
K241168 · Wassenburg Medical, Inc. · Dec 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · STERIS Corporation · Dec 2024
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · STERIS Corporation · Jun 2023
SCOPE BUDDY PLUS Endoscope Flushing Aid
K213833 · Medivators, Inc. · Jan 2022
Endoscope Reprocessor OER-Elite
K201920 · Olympus Medical Systems Corp. · Sep 2020
System 83 Plus Washer/Disinfector
K173590 · Custom Ultrasonics, Inc. · Mar 2020