510(k) · Cleared

Cleared

CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5

K051305510(k) TraditionalCleared Aug 18, 200591-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 Aug 18, 2005 as substantially equivalent to K914145 (Medivators, Inc., 1994) and 2 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.

Decided: Aug 18, 2005
Review: 91 days
Class: Class II
Product code: PSW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K914145 (1994). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK914145 DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 1994 · Recalled
This deviceK051305 CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100…Cs Medical, LLC · 2005
Descendant · cites it directly · 3 of its ownK103059 TrophonNanosonics Limited · 2011 · Recalled
Descendant · 2 generations on · 2 of its ownK173865 trophon2Nanosonics Limited · 2018
Descendant · cites it directly · 2 of its ownK160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level…Cs Medical, LLC · 2016
Descendant · 2 generations on · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
Descendant · cites it directly · 1 of its ownK150504 GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR…Pci Medical, Inc. · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011high 1 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all

K103059TrophonNanosonics Limited · 2011 · cites it directly3descendants
K173865trophon2Nanosonics Limited · 2018 · 2 generations on2descendants
K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC · 2016 · cites it directly2descendants
K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC · 2020 · 2 generations on1descendant
K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal…Pci Medical, Inc. · 2015 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914145	DSD-91(TM) Disinfector for Flexible Endoscopes	Medivators, Inc.	1994	1
0 (this device)	K051305	CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical…	Cs Medical, LLC	2005	—
+1	K103059	Trophon	Nanosonics Limited	2011	1
+2	K173865	trophon2	Nanosonics Limited	2018	—
+1	K160921	CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS…	Cs Medical, LLC	2016	—
+2	K192228	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical…	Cs Medical, LLC	2020	—
+1	K150504	GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR…	Pci Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2020	1	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K051305, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K233049 TD 200® Automated TEE Probe Disinfector with…score 7.9 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K914145	DSD-91(TM) Disinfector for Flexible Endoscopes Summary page 4 …sories. 21 C.F.R. § 876.1500. High Level Liquid Chemical Disinfectant. 21 C.F.R. § 880.6885. Predicate Devices: (1) Medivators DSD™ Disinfector For Flexible Endoscopes (K914145) (2) Wavicide-01 (K914749) (3) Medivators Rapicide™ 5 Minute High-Level Disinfectant (K993042) The DSD system uses a High-level…	Medivators, Inc.	1994	1
*	K914749	Wavicide (R) -01 Summary page 4 …00. High Level Liquid Chemical Disinfectant. 21 C.F.R. § 880.6885. Predicate Devices: (1) Medivators DSD™ Disinfector For Flexible Endoscopes (K914145) (2) Wavicide-01 (K914749) (3) Medivators Rapicide™ 5 Minute High-Level Disinfectant (K993042) The DSD system uses a High-level Disinfectant to reprocess…	Wave Energy Systems, Inc.	1995	—
*	K993042	Medivators 5 Minute High-Level Disinfectant Summary page 4 …Predicate Devices: (1) Medivators DSD™ Disinfector For Flexible Endoscopes (K914145) (2) Wavicide-01 (K914749) (3) Medivators Rapicide™ 5 Minute High-Level Disinfectant (K993042) The DSD system uses a High-level Disinfectant to reprocess reusable flexible endoscopes. It controls the environmental conditio…	Medivators, Inc.	2000	—

Also cleared against K914145: 4 other devices →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103059	Trophon	Nanosonics Limited	2011	3
K160921	CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…	Cs Medical, LLC	2016	2
K150504	GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal…	Pci Medical, Inc.	2015	1

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K103059 (Nanosonics Limited, 2011) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K914145.

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.

FDA decisions per year · PSW

2in 2023

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	1	—	0
2021	0	—	0
2022	0	—	0
2023	2	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The TD-100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses the TD-5 disinfectant, which is designed to be used only with the TD-100. The disinfectant bottles cannot be reused in the system. TD-5 is intended for use as a single use high-level disinfectant to be used exclusively in the TD-100 for the high-level disinfection of TEE ultrasound probes. TD-5 High Level Disinfectant should…

Read the full statement (112 words)

The TD-100 disinfector is designed to provide high-level disinfection of

Transesophageal (TEE) ultrasound probes. The system uses the TD-5 disinfectant,

which is designed to be used only with the TD-100. The disinfectant bottles cannot be

reused in the system.

TD-5 is intended for use as a single use high-level disinfectant to be used exclusively

in the TD-100 for the high-level disinfection of TEE ultrasound probes.

TD-5 High Level Disinfectant should be used with the following contact conditions:

Minimum

Time Temperature Recommended

, Concentration

High Level . o

Disinfection 5 Minutes 38-40°C 1.7%

The TD-5 High Level Disinfectant and TD-100 disinfector system is intended for use

by qualified individuals trained in its use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K051305 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051305

Report an extraction error

Are you the manufacturer?

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