510(k) · Cleared
ClearedCS-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
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 3, 2016 as substantially equivalent to K051305 (Cs Medical, LLC, 2005) and 3 other predicates after a 213-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 213 days
- Class
- Class II
- Product code
- PSW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K991487 (1999). 8 ancestors in all, the oldest K914145 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK991487 Cidex Opa SolutionAdvanced Sterilization Products · 1999
- 3 generations backK030004 0.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products · 2003 · Recalled
- 2 generations backK070627 Opaciden SolutionCiden Technologies, LLC · 2007
- 1 generation backK120306 Rapicide Opa-28Minntech Corp. · 2012
- This deviceK160921 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level…Cs Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK192228 CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS…Cs Medical, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK233049 TD 200® Automated TEE Probe Disinfector with TD-12® High-Level…Cs Medical, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991487 | Cidex Opa Solution | Advanced Sterilization Products | 1999 | — |
| −3 | K030004 | 0.55% Orth-Phthalaldehyde Solution | Advanced Sterilization Products | 2003 | 2 |
| −2 | K070627 | Opaciden Solution | Ciden Technologies, LLC | 2007 | — |
| −1 | K120306 | Rapicide Opa-28 | Minntech Corp. | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Summary page 4…ants 892.1570, Primary Product Code ITX) Legally Marketed Predicate Devices 1. CS Medical TD 100® Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) — Primary Predicate 2. Rapicide OPA-28% (K120306) 3. 4. Cidex OPA (K030004) Metricide OPA Plus (K070627 as Opaciden Solution)… | 2005 |
| * | K120306 | Rapicide Opa-28Summary page 4…Marketed Predicate Devices 1. CS Medical TD 100® Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) — Primary Predicate 2. Rapicide OPA-28% (K120306) 3. 4. Cidex OPA (K030004) Metricide OPA Plus (K070627 as Opaciden Solution) Description of the CS Medical TD 10… | 2012 |
| * | K070627 | Opaciden SolutionSummary page 4…esophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) — Primary Predicate 2. Rapicide OPA-28% (K120306) 3. 4. Cidex OPA (K030004) Metricide OPA Plus (K070627 as Opaciden Solution) Description of the CS Medical TD 100° Disinfector with TD-5® and TD-8% High Level Disinfect… | 2007 |
| * | K030004 | 0.55% Orth-Phthalaldehyde SolutionSummary page 4…1. CS Medical TD 100® Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) — Primary Predicate 2. Rapicide OPA-28% (K120306) 3. 4. Cidex OPA (K030004) Metricide OPA Plus (K070627 as Opaciden Solution) Description of the CS Medical TD 100° Disinfector with TD-5®… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12… | 2020 | 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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K192228 (Cs Medical, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051305.
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. 2016, 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 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-5® or TD-8® disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system. TD-5® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound…
Read the full statement (196 words)
The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-5® or TD-8® disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system.
TD-5® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes.
TD-5® high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use.
TD-5® disinfectant should be used with the following contact conditions in TD 100® disinfector:
High-Level Disinfectant: TD-5®; Time: 5 minutes; Temperature: 38°C - 40°C; Minimum Recommended Concentration: 1.7% glutaraldehyde
TD-8® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes.
TD-8® high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use.
TD-8® disinfectant should be used with the following contact conditions in TD 100® disinfector:
High-Level Disinfectant: TD-8®; Time: 5 minutes; Temperature: 38°C - 40°C; Minimum Recommended Concentration: 0.3% ortho-phthalaldehyde
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/K160921 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160921
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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