Cleared Traditional

K152189 - EVOTECH ECR (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152189 · Advanced Sterilization Products (Asp) · General Hospital
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Jul 2016
Decision
350d
Days
Class 2
Risk

K152189 is an FDA 510(k) clearance for the EVOTECH ECR. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Asp) (Irvin, US). The FDA issued a Cleared decision on July 20, 2016 after a review of 350 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 Advanced Sterilization Products (Asp) devices

Submission Details

510(k) Number K152189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2015
Decision Date July 20, 2016
Days to Decision 350 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 128d · This submission: 350d
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 56
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K152189.
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