# PSW: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

- Device class: 2; regulation: 21 CFR 892.1570; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 86 days (middle half 71–100)
- 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)
- 2005: 1
- 2015: 1
- 2016: 1
- 2019: 1
- 2020: 1
- 2023: 2

## Most-cited predicates
- K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5 (2005), cited by 3
- K160921: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (2016), cited by 1
- K182891: TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (2019), cited by 1
- K150504: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor (2015), cited by 1
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), cited by 1

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