# K252158: Sagami Original 002 Polyurethane Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Mayer Laboratories
- Decided: Mar 30, 2026 after 264 days
- Product code: MOL (Condom, Synthetic)
- 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 K100767 (2011). 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)
- K203541: Okamoto 002 Lubricated Polyurethane Male Condom, Okamoto USA, Inc. (2022) Summary page 5.

## Indications for use
Sagami Original 002 Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Source page: https://510kreport.com/device/K252158
Methodology: https://510kreport.com/methodology