# K946374: Kimono Microthin

- Pathway: 510(k) (Traditional)
- Applicant: Mayer Laboratories
- Decided: Nov 8, 1995 after 329 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.
5 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090259: Okamoto Ultra Thin (2009), 3 descendants of its own
- 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
- K113686: Kimono Microthin with Aqua Lube, Reality Ultra Lubricated (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K946374
Methodology: https://510kreport.com/methodology