# K051305: CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5 High-Level Disinfectant, Model TD-5

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, LLC
- Decided: Aug 18, 2005 after 91 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 K914145 (1994). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes, Medivators, Inc. (1994) Summary page 4.
- K914749: Wavicide (R) -01, Wave Energy Systems, Inc. (1995) Summary page 4.
- K993042: Medivators 5 Minute High-Level Disinfectant, Medivators, Inc. (2000) Summary page 4.

## Most influential descendants
- K103059: Trophon (2011), 3 descendants of its own
- K173865: trophon2 (2018), 2 descendants of its own
- 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), 2 descendants of its own
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (2020), 1 descendant of its own
- K150504: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor (2015), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K051305
Methodology: https://510kreport.com/methodology