# K090259: Okamoto Ultra Thin

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: Mar 31, 2009 after 57 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: 1 generation back to K872812 (1987). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K872812: Skinless-Skin, Pink Tint (Condom), Okamoto USA, Inc. (1987) Summary page 1.
- K946374: Kimono Microthin, Mayer Laboratories (1995) Summary page 1.

## Most influential descendants
- K192669: Extremely Thin 003, ZERO ZERO THREE (2020), 2 descendants of its own
- K252622: Male Latex Condom HA (2026), 0 descendants of its own
- K213921: Microthin Natural Rubber Latex Condom (2022), 0 descendants of its own

## Indications for use
The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K090259
Methodology: https://510kreport.com/methodology