Cleared Special

RELIANCE ENDOSCOPE PROCESSING SYSTEM (K110453) - FDA 510(k) Clearance

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

K110453 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
28d
Days
Class 2
Risk

K110453 is an FDA 510(k) clearance for the RELIANCE ENDOSCOPE PROCESSING SYSTEM. Classified as Accessories, Germicide, Cleaning, For Endoscopes (product code NZA), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 16, 2011 after a review of 28 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 STERIS Corporation devices

Submission Details

510(k) Number K110453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2011
Decision Date March 16, 2011
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K110453.
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
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · Steris · Jan 2021
Reliance Endoscope Processing System
K200989 · STERIS Corporation · May 2020