# K091769: Trust Dam

- Pathway: 510(k) (Abbreviated)
- Applicant: Line One Laboratories, Inc.
- Decided: Feb 5, 2010 after 234 days
- Product code: MSC (Barrier, Std, Oral Sex)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990067 (1999). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990067: Sheer Glyde Dams, Louise C. Myers (1999) Summary page 1.

## Most influential descendants
- K212928: Lorals (2022), 1 descendant of its own
- K253662: Lixi (LXOSFM1) (2026), 0 descendants of its own
- K212037: SancDam Latex Oral Dam (2022), 0 descendants of its own
- K203727: Harmony Latex Dam, Harmony Non-Latex Dam (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091769
Methodology: https://510kreport.com/methodology