Cleared Special

K200989 - Reliance Endoscope Processing System

K200989 is an FDA 510(k) clearance for Reliance Endoscope Processing System, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code NZA cleared through the Special 510(k) pathway after a 29-day FDA review.

K200989 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
29d
Days
Class 2
Risk

K200989 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 May 14, 2020 after a review of 29 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.

FDA 510(k) Submission Details - K200989

510(k) Number K200989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2020
Decision Date May 14, 2020
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

NZA Device Classification - Class 2, Special Controls

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 K200989.
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 ADVANCE ENDOSCOPE PROCESSING SYSTEM
K123768 · STERIS Corporation · Jul 2013
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K110453 · STERIS Corporation · Mar 2011
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K102244 · STERIS Corporation · Dec 2010
K200989 · Reliance Endoscope Processing System
Download PDF FDA Summary STERIS Corporation