510(k) Report

510(k) · Cleared

Cleared

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

K230381510(k) TraditionalCleared Jun 7, 2023114-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cs Medical, LLC · PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Cleared on Jun 7, 2023 as substantially equivalent to K182891 (Cs Medical, LLC, 2019) after a 114-day review. Its family tree reaches back 1 generation to 2019.

Decided
Jun 7, 2023
Review
114 days
Class
Class II
Product code
PSW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K182891 (2019). No later device cites it as a predicate yet.

Reference device: K192228 · CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant · Cs Medical, LLC · 2020K182891 · 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 · 201920162018202020222024
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 · 20190
  1. Root · 1 generation backK182891 TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme…Cs Medical, LLC · 2019
  2. This deviceK230381 Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide…Cs Medical, LLC · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner…Cs Medical, LLC2019—
0 (this device)K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide…Cs Medical, LLC2023—
FIG. 1 — Lineage of K230381, 2019–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PSW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PSW device

  1. #1 K233049 TD 200® Automated TEE Probe Disinfector with…score 7.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and…
Summary page 4
…PSW) QwikCheck Chemical Indicator Legally Marketed Predicate Devices TEEClean Automated TEE Probe Cleaner Disinfector with TEEZyme and TD-5 or TD-8 (K182891) – Primary Predicate Device Reference Device TD 200 Automated TEE Probe Disinfector with TD-12 and QwikCheck (K192228)…
Cs Medical, LLC2019—
†K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC2020—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All PSW devices

PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · PSW

2in 2023

2015: 12016: 12019: 12020: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSW

Too few PSW 510(k)s in any year since 2007 to give a median.

Recalls per year · PSW

No recall names PSW since 2007.

Adverse event reports per year · PSW

No MAUDE report names PSW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20161—00
20170—00
20180—00
20191—00
20201—00
20210—00
20220—00
20232—00
20240—00
20250—00
20260—0—

What is it indicated for?

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…

Read the full statement (165 words)

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.

Indications for use as stated in the FDA summary.

More from Cs Medical, LLC

6 FDA decisions under this applicant name. See the company

  • K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 2019
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 2016
  • K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant…Cs Medical, LLC · 2005

Recent decisions in PSW

The PSW category page

  • K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High…Cs Medical, LLC · 2019
  • K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level…Cs Medical, LLC · 2016
  • K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe ReprocessorPci Medical, Inc. · 2015

https://510kreport.com/device/K230381 · printed Nov 3, 2026

Cite this page

510(k) Report. “K230381: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K230381

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026