# K192669: Extremely Thin 003, ZERO ZERO THREE

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: Jul 24, 2020 after 303 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: 2 generations back to K872812 (1987). 3 ancestors in all.
2 later devices descend from it; 2 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)
- K090259: Okamoto Ultra Thin, Okamoto USA, Inc. (2009) Summary page 4.

## Most influential descendants
- 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 contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K192669
Methodology: https://510kreport.com/methodology