# K230381: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, LLC
- Decided: Jun 7, 2023 after 114 days
- Product code: PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K182891 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182891: TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants, Cs Medical, LLC (2019) Summary page 4.

## Indications for use
The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. AquaCide cleaner/disinfectant is intended for use as a single use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes. AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector: High-level Disinfectant Time Temperature Minimum Recommended Concentration AquaCide 3 minutes 47oC 1750 ppm peracetic acid The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm. The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified individuals trained in its use.

Source page: https://510kreport.com/device/K230381
Methodology: https://510kreport.com/methodology