De Novo · Granted
GrantedTristel Duo ULT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tristel Solutions Limited · QWS Foam Or Gel Chemical Sterilant/High Level Disinfectant
Granted on Jun 2, 2023 as a new device type through De Novo after a 338-day review. 1 later device descends from it.
- Decided
- Jun 2, 2023
- Review
- 338 days
- Class
- Class II
- Product code
- QWS
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN220041 Tristel Duo ULTTristel Solutions Limited · 2023
- Descendant · cites it directly · 0 of its ownK242732 Tristel OPHTristel Solutions, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242732Tristel OPHTristel Solutions, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | 2023 | — |
| +1 | K242732 | Tristel OPH | Tristel Solutions, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 QWS? 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 QWS device
- #1 K242732 Tristel OPHscore 9.3 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242732 | Tristel OPH | 2025 | 0 |
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?
- Of its descendants, K242732 (Tristel Solutions, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QWS devicesQWS Foam Or Gel Chemical Sterilant/High Level Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWS
Too few QWS 510(k)s in any year since 2007 to give a median.
Recalls per year · QWS
No recall names QWS since 2007.
Adverse event reports per year · QWS
No MAUDE report names QWS 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Tristel Duo ULT is a high level disinfect foam for reprocessing ultrasound probes. It can be used to high level disinfect endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin during use. Tristel Duo ULT is a high level disinfectant when used in accordance with the directions for use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum…
Read the full statement (206 words)
Tristel Duo ULT is a high level disinfect foam for reprocessing ultrasound probes. It can be used to high level disinfect endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin during use.
Tristel Duo ULT is a high level disinfectant when used in accordance with the directions for use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC).
Tristel Duo ULT must be applied on the surface of an ultrasound probe using Duo Wipes. Duo Wipes are intended to apply Tristel Duo ULT foam on the surface of ultrasound probes and to remove residue of the foam after high level disinfection.
Each dose of Tristel Duo ULT foam and each Duo Wipe are single use.
The semi-critical ultrasound probes reprocessed by Tristel Duo ULT must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers’ instructions.
Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel Duo ULT may be verified using Duo Test Strips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220041 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220041: Tristel Duo ULT.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220041
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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