AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
FDA 510(k) K222849 · Steris
Submission
- Device name
- AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
- Applicant
- Steris
Mentor, OH, US - Received
- September 21, 2022
- Decision date
- September 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVE – Washer, Cleaner, Automated, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that…
Other 510(k)s with product code NVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…NVE · Special | Steris | 08/25/2022SE |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…NVE · Special | STERIS Corporation | 12/01/2020SE |
| K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…NVE · Special | STERIS Corporation | 04/03/2020SE |
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…NVE · Traditional | STERIS Corporation | 08/21/2019SE |
| K073112 | Da Vinci Sonicpro Cleaning System, Model 400253NVE · Traditional | Intuitive Surgical, Inc. | 08/01/2008SE |
| K043314 | Manzi Cleaner SystemNVE · Traditional | Langford IC Systems, Inc. | 06/20/2005SE |
| K983017 | Modification to System 83 PlusNVE · Special | Custom Ultrasonics | 09/22/1998SE |
| K871712 | Machida America Model AC-5000 Automatic Disinfect.NVE · Traditional | Machida America, Inc. | 01/14/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | Keymed, Inc. | 02/12/1987SE |
| K862402 | Ott Disinfector for Flexible EndoscopesNVE · Traditional | Medivators, Inc. | 02/03/1987SE |
More from Medivators, 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 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector cleared by the FDA?
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849) received a 510(k) decision of Substantially Equivalent on September 30, 2022, 9 days after the submission was received.
What is the product code of K222849?
The FDA product code is NVE – Washer, Cleaner, Automated, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.