FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
K Number: K190081
·
Decision Aug 21, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
11
Applicant Total
204
Review Days
217
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
- K Number
- K190081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- January 16, 2019
- Decision Date
- August 21, 2019
- Product Code
- NVE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVE | Washer, Cleaner, Automated, Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NVE), ordered by most recent decision date.
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)
FDA Class 2
·Gastroenterology, Urology
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 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)
FDA Class 2
·Gastroenterology, Urology
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANZI CLEANER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by STERIS Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | Apr 8, 2026 | Substantially Equivalent |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | Apr 8, 2026 | Substantially Equivalent |
| K252680 | Celerity 20 HP Biological Indicator | Sep 24, 2025 | Substantially Equivalent |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | May 2, 2025 | Substantially Equivalent |
| K243876 | VERIFY STEAM Integrating Indicator | Apr 25, 2025 | Substantially Equivalent |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | Apr 18, 2025 | Substantially Equivalent |
| K250061 | Celerity Incubator | Feb 6, 2025 | Substantially Equivalent |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Feb 6, 2025 | Substantially Equivalent |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | Dec 4, 2024 | Substantially Equivalent |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | Dec 2, 2024 | Substantially Equivalent |