Cleared Traditional

K203223 - Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (FDA 510(k) Clearance)

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

K203223 · Steris · General Hospital
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Jan 2021
Decision
87d
Days
Class 2
Risk

K203223 is an FDA 510(k) clearance for the Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide. Classified as Accessories, Germicide, Cleaning, For Endoscopes (product code NZA), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Steris devices

Submission Details

510(k) Number K203223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date January 28, 2021
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZA Accessories, Germicide, Cleaning, For Endoscopes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition High Level Disinfection Of Reusable, Heat-sensitive Devices 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 - NZA Accessories, Germicide, Cleaning, For Endoscopes

All 10
Devices cleared under the same product code (NZA) and FDA review panel - the closest regulatory comparables to K203223.
enspire 300 Series Automated Endoscope Reprocessor
K232918 · STERIS Corporation · Oct 2023
enspire 300 Series Automated Endoscope Reprocessor System
K230560 · STERIS Corporation · Jul 2023
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361 · STERIS Corporation · Mar 2022