510(k) Report

510(k) · Cleared

Cleared

TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

K182891510(k) TraditionalCleared Apr 12, 2019179-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 Apr 12, 2019 after a 179-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Apr 12, 2019
Review
179 days
Class
Class II
Product code
PSW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared201620182020202220242026
  1. This deviceK182891 TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme…Cs Medical, LLC · 2019
  2. Descendant · cites it directly · 0 of its ownK230381 Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide…Cs Medical, LLC · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level…Cs Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K182891TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner…Cs Medical, LLC2019—
+1K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide…Cs Medical, LLC2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K182891, 2019–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level…Cs Medical, LLC20230

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?

  • Of its descendants, K230381 (Cs Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.

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. 2019, 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—

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
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and…Cs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • 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
  • K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and…Cs Medical, LLC · 2023
  • K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC · 2020
  • 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/K182891 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182891: TEEClean (R) Automated TEE Probe Cleaner Disinfector with TEEZyme (R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182891

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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