# K233049: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Cs Medical, LLC
- Decided: Nov 21, 2023 after 57 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: 6 generations back to K991487 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192228: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant, Cs Medical, LLC (2020) Summary page 5.

## Cited in the summary but kept off the family tree
- K964264: High Range Peroxide Test Strip, Integrated Biomedical Technology, Inc. (1997). Our reading of the summary gave K964264, FDA’s number for High Range Peroxide Test Strip (Integrated Biomedical Technology, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “IBT Scientific Peracid Test”. Kept off the family tree. Summary page 5.

## Indications for use
The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators 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 1750 ppm peracetic acid QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.

Source page: https://510kreport.com/device/K233049
Methodology: https://510kreport.com/methodology