# K897129: Condoms (Multiple Brands)

- Pathway: 510(k) (Traditional)
- Applicant: Sagami, Inc.
- Decided: May 16, 1990 after 141 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.
17 later devices descend from it; 2 cite it directly.
0 of 18 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
- K071313: Trojan-Enz Brand (2007), 13 descendants of its own
- K071272: Trojan Thintensity Brand Male Latex Condom (2007), 8 descendants of its own
- K073016: Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm Sensations Lubricant (2007), 7 descendants of its own
- K103119: Billy Boy Male Latex Condom (2011), 5 descendants of its own
- K083817: M. Dior Brand (2009), 5 descendants of its own

Source page: https://510kreport.com/device/K897129
Methodology: https://510kreport.com/methodology