# K013433: Trojan Passion Berry Gel

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Mar 5, 2002 after 140 days
- Product code: NUC (Lubricant, Personal)
- 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 K890863 (1989). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890863: Trojan for Women, Armkel, LLC (1989) Summary page 1.
- (no number) HeR® Lubricating Jelly: named in the summary without a submission number

## Most influential descendants
- K023405: Trojan Mint Tingle Brand Latex Condoms (2002), 6 descendants of its own
- 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

## Indications for use
The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.

Source page: https://510kreport.com/device/K013433
Methodology: https://510kreport.com/methodology