# K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, LLC
- Decided: Apr 1, 2020 after 229 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: 5 generations back to K991487 (1999). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Cs Medical, LLC (2016) Summary page 4.
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant, Medivators Reprocessing Systems (2009) Summary page 4.

## Most influential descendants
- K233049: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (2023), 0 descendants of its own

## Indications for use
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system. TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes. TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use. TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector: High-level disinfectant Time Temperature Minimum Recommended Concentration TD-12® 3 minutes 38°C 1.75% peracetic acid

Source page: https://510kreport.com/device/K192228
Methodology: https://510kreport.com/methodology