# K203727: Harmony Latex Dam, Harmony Non-Latex Dam

- Pathway: 510(k) (Traditional)
- Applicant: Pamco Distributing, Inc.
- Decided: Aug 5, 2021 after 227 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: 2 generations back to K990067 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091769: Trust Dam, Line One Laboratories, Inc. (2010) Summary page 4.

## Indications for use
The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.

Source page: https://510kreport.com/device/K203727
Methodology: https://510kreport.com/methodology