# K063227: Conceivex Conception Kit

- Pathway: 510(k) (Traditional)
- Applicant: Conceivex, Inc.
- Decided: Mar 14, 2007 after 141 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: 1 generation back to K902936 (1991). 2 ancestors in all.
3 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)
- K993953: Oves Cervical Cap, Veos, Ltd. (2000) Summary page 1.
- K902936: Polyurethane Condom, Apex Medical Technologies, Inc. (1991) Summary page 1.

## Most influential descendants
- K112200: Focus Touch Conception System (2012), 1 descendant of its own
- K140186: The Stork Otc (2014), 0 descendants of its own
- K080752: Conceivex Latex-Free Semen Collector (2008), 0 descendants of its own

## Indications for use
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.

Source page: https://510kreport.com/device/K063227
Methodology: https://510kreport.com/methodology