Cleared Traditional

System 83 Plus Washer/Disinfector (K173590) - FDA 510(k) Clearance

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

K173590 · Custom Ultrasonics, Inc. · General Hospital
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Mar 2020
Decision
860d
Days
Class 2
Risk

K173590 is an FDA 510(k) clearance for the System 83 Plus Washer/Disinfector. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Custom Ultrasonics, Inc. (Ivyland, US). The FDA issued a Cleared decision on March 30, 2020 after a review of 860 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Custom Ultrasonics, Inc. devices

Submission Details

510(k) Number K173590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2017
Decision Date March 30, 2020
Days to Decision 860 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
731d slower than avg
Panel avg: 129d · This submission: 860d
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 K173590.
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
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · Olympus Medical Systems Corp. · Jul 2019