Cleared Traditional

K230560 - enspire 300 Series Automated Endoscope Reprocessor System

K230560 is an FDA 510(k) clearance for enspire 300 Series Automated Endoscope ..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code NZA cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K230560 · STERIS Corporation · General Hospital
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Jul 2023
Decision
143d
Days
Class 2
Risk

K230560 is an FDA 510(k) clearance for the enspire 300 Series Automated Endoscope Reprocessor 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 July 21, 2023 after a review of 143 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 STERIS Corporation devices

FDA 510(k) Submission Details - K230560

510(k) Number K230560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2023
Decision Date July 21, 2023
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K230560.
enspire 300 Series Automated Endoscope Reprocessor
K232918 · STERIS Corporation · Oct 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
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
K123768 · STERIS Corporation · Jul 2013
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K110453 · STERIS Corporation · Mar 2011