510(k) · Cleared
ClearedTD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cs Medical, LLC · PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Cleared on Nov 21, 2023 as substantially equivalent to K192228 (Cs Medical, LLC, 2020) after a 57-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Nov 21, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- PSW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K991487 (1999). 16 ancestors in all, the oldest K914145 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK991487 Cidex Opa SolutionAdvanced Sterilization Products · 1999
- 5 generations backK030004 0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products · 2003 · Recalled
- 4 generations backK070627 Opaciden SolutionCiden Technologies, LLC · 2007
- 3 generations backK120306 Rapicide Opa-28Minntech Corp. · 2012
- 2 generations backK160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level…Cs Medical, LLC · 2016
- 1 generation backK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
- This deviceK233049 TD 200® Automated TEE Probe Disinfector with TD-12® High-Level…Cs Medical, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991487 | Cidex Opa Solution | Advanced Sterilization Products | 1999 | — |
| −5 | K030004 | 0.55% Orth-Phthalaldehyde Solution | Advanced Sterilization Products | 2003 | 2 |
| −4 | K070627 | Opaciden Solution | Ciden Technologies, LLC | 2007 | — |
| −3 | K120306 | Rapicide Opa-28 | Minntech Corp. | 2012 | — |
| −2 | K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS… | Cs Medical, LLC | 2016 | — |
| −1 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical… | Cs Medical, LLC | 2020 | — |
| 0 (this device) | K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant… | Cs Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
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 K230381 Ethos Automated Ultrasound Probe Cleaner…score 5.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Summary page 5…ct Code, MED, JOJ Legally Marketed Predicate Devices 1. TD 200/TD-12 disinfector/disinfectant system (K192228) – Primary Predicate 2. IBT Scientific Peracid Test (K964264) Description of the CS Medical TD 200® Disinfector with TD-12® Hig… | 2020 |
| Kept off the family tree | K964264 | FDA’s K964264 is High Range Peroxide Test Strip 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…MED, JOJ Legally Marketed Predicate Devices 1. TD 200/TD-12 disinfector/disinfectant system (K192228) – Primary Predicate 2. IBT Scientific Peracid Test (K964264) Description of the CS Medical TD 200® Disinfector with TD-12® High Level Disinfectant and QwikCheck™ Indicator The TD 200 disin… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 16 ancestors have a recall of any class.
How does its category compare?
All PSW devicesPSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PSW
2in 2023
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233049: TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233049
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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