510(k) · Cleared
ClearedTristel OPH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tristel Solutions, Ltd. · QWS Foam Or Gel Chemical Sterilant/High Level Disinfectant
Cleared on May 9, 2025 as substantially equivalent to DEN220041 (Tristel Solutions Limited, 2023) after a 241-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 9, 2025
- Review
- 241 days
- Class
- Class II
- Product code
- QWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220041 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220041 Tristel Duo ULTTristel Solutions Limited · 2023
- This deviceK242732 Tristel OPHTristel Solutions, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | 2023 | — |
| 0 (this device) | K242732 | Tristel OPH | Tristel Solutions, Ltd. | 2025 | — |
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 QWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN220041 | Tristel Duo ULTSummary page 5…sterilant/high level disinfectant Regulation Number: 21 CFR 880.6886 Product Code: QWS Regulatory Class: II III. PREDICATE DEVICE Predicate Device: Tristel Duo ULT (DEN220041) IV. DEVICE DESCRIPTION Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be us… | 2023 |
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?
- Its one ancestor has no recall.
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. 2025, 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 OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes. Tristel OPH is a high level disinfectant when used in accordance with the Directions for Use, including a disinfection contact time of 2 minutes, at room…
Read the full statement (211 words)
Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to
high level disinfect devices that may contact mucous membranes during use, such as diagnostic and
laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes.
Tristel OPH 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 OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes.
Tristel OPH Wipes are intended for application of Tristel OPH Foam on the surface of ophthalmic
devices and to remove residue of the foam after high level disinfection.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.
The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a
validated cleaning protocol or standard and following the device manufacturers’ instructions.
Tristel OPH 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
OPH may be verified using Tristel Test Strips.
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/K242732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242732: Tristel OPH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242732
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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