# K904375: Kimono Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mayer Laboratories
- Decided: Nov 26, 1990 after 62 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103119: Billy Boy Male Latex Condom (2011), 5 descendants of its own
- K120394: Lifestyles Zero Lubricated Latex Condom (2012), 1 descendant of its own
- K111093: Billy Boy Male Latex Condom (2011), 1 descendant of its own
- K153016: aoni Natural Rubber Latex Condom (2016), 0 descendants of its own
- K141256: Okamoto Studded Condom (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K904375
Methodology: https://510kreport.com/methodology