# K112200: Focus Touch Conception System

- Pathway: 510(k) (Traditional)
- Applicant: Intimate Bridge 2 Conception, Inc.
- Decided: Sep 6, 2012 after 402 days
- Product code: OBB (Kit, Conception-Assist, Home Use)
- Device class: 2
- Regulation: 21 CFR 884.5250
- 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 K902936 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063227: Conceivex Conception Kit, Conceivex, Inc. (2007) Summary page 1.

## Most influential descendants
- K140186: The Stork Otc (2014), 0 descendants of its own

## Indications for use
The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.

Source page: https://510kreport.com/device/K112200
Methodology: https://510kreport.com/methodology