# DEN220041: Tristel Duo ULT

- Pathway: De Novo (Direct)
- Applicant: Tristel Solutions Limited
- Decided: Jun 2, 2023 after 338 days
- Product code: QWS (Foam Or Gel Chemical Sterilant/High Level Disinfectant)
- Device class: 2
- Regulation: 21 CFR 880.6886
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K242732: Tristel OPH (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN220041
Methodology: https://510kreport.com/methodology