# K150828: O-RING Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: O-Ring Products, LLC
- Decided: Dec 18, 2015 after 263 days
- Product code: HIS (Condom)
- 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: 3 generations back to K897129 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083817: M. Dior Brand, Suzhou Colour-Way Enterprise Development Co., Ltd. (2009) Summary page 4.

## Indications for use
The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K150828
Methodology: https://510kreport.com/methodology