# NVE: Washer, Cleaner, Automated, Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 6 days (middle half 5–8)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1983: 1
- 1987: 2
- 1988: 1
- 1998: 1
- 2005: 1
- 2008: 1
- 2019: 1
- 2020: 2
- 2022: 2

## Most-cited predicates
- K983017: Modification to System 83 Plus (1998), cited by 2
- K043314: Manzi Cleaner System (2005), cited by 2
- K222543: 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 (2022), cited by 1
- K203199: RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (2020), cited by 1
- K200577: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2020), cited by 1
- K190081: RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (2019), cited by 1
- K073112: DA Vinci Sonicpro Cleaning System, Model 400253 (2008), cited by 1

Source page: https://510kreport.com/product-code/NVE
Data by year (CSV): https://510kreport.com/product-code/NVE.csv