Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
FDA 510(k) K220361 · STERIS Corporation
510(k) numberK220361
Submission
- Device name
- Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- February 8, 2022
- Decision date
- March 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZA – Accessories, Germicide, Cleaning, For Endoscopes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code NZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232918 | enspire 300 Series Automated Endoscope ReprocessorNZA · Special | STERIS Corporation | 10/03/2023SE |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor SystemNZA · Traditional | STERIS Corporation | 07/21/2023SE |
| K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA · Traditional | Steris | 01/28/2021SE |
| K200989 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 05/14/2020SE |
| K123768 | Reliance Advance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 07/26/2013SE |
| K110453 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 03/16/2011SE |
| K102244 | Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/03/2010SE |
| K040049 | The Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/17/2004SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | Keymed, Inc. | 06/17/1986SE |
| K841331 | Olympus KC-10 Mobile Disinfec-StatNZA · Traditional | Keymed, Inc. | 07/19/1984SE |
More from Keymed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | 06/24/2026SE |
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | 04/08/2026SE |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | 09/24/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | 06/06/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | 04/25/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | 04/18/2025SE |
| K242773 | Electro Lube NXTGEI · Traditional | 04/15/2025SE |
| K250061 | Celerity IncubatorFRC · Special | 02/06/2025SE |
Questions and answers
When was Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide cleared by the FDA?
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K220361) received a 510(k) decision of Substantially Equivalent on March 10, 2022, 30 days after the submission was received.
What is the product code of K220361?
The FDA product code is NZA – Accessories, Germicide, Cleaning, For Endoscopes, a Class II (moderate risk) device regulated under 21 CFR 876.1500.