510(k) · Cleared
ClearedTrust Dam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Line One Laboratories, Inc. · MSC Barrier, Std, Oral Sex
Cleared on Feb 5, 2010 as substantially equivalent to K990067 (Louise C. Myers, 1999) after a 234-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Feb 5, 2010
- Review
- 234 days
- Class
- Class II
- Product code
- MSC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990067 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK990067 Sheer Glyde DamsLouise C. Myers · 1999
- This deviceK091769 Trust DamLine One Laboratories, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK212928 LoralsBrazen Goods Inc. Dba Lorals · 2022
- Descendant · 2 generations on · 0 of its ownK253662 Lixi (LXOSFM1)Luwi, LLC · 2026
- Descendant · cites it directly · 0 of its ownK212037 SancDam Latex Oral DamSanctuary Health Sdn. Bhd. · 2022
- Descendant · cites it directly · 0 of its ownK203727 Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K212928LoralsBrazen Goods Inc. Dba Lorals · 2022 · cites it directly1descendant
- K253662Lixi (LXOSFM1)Luwi, LLC · 2026 · 2 generations on0descendants
- K212037SancDam Latex Oral DamSanctuary Health Sdn. Bhd. · 2022 · cites it directly0descendants
- K203727Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990067 | Sheer Glyde Dams | Louise C. Myers | 1999 | — |
| 0 (this device) | K091769 | Trust Dam | Line One Laboratories, Inc. | 2010 | — |
| +1 | K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022 | — |
| +2 | K253662 | Lixi (LXOSFM1) | Luwi, LLC | 2026 | — |
| +1 | K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022 | — |
| +1 | K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 MSC? 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 MSC device
- #1 K253662 Lixi (LXOSFM1)score 12.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K990067 | Sheer Glyde DamsSummary page 1…Common Name: Latex Dams Classification Name: Latex Dams Predicate Devices: Sheer Glyde Dams K990067 Description of Device: This oral dam is made of natural rubber latex, which completely covers… | 1999 |
| † | K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring) | 2007 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K212928 (Brazen Goods Inc. Dba Lorals, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MSC devicesMSC Barrier, Std, Oral Sex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MSC
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSC
Too few MSC 510(k)s in any year since 2007 to give a median.
Recalls per year · MSC
No recall names MSC since 2007.
Adverse event reports per year · MSC
No MAUDE report names MSC 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 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091769: Trust Dam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091769
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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