# K080752: Conceivex Latex-Free Semen Collector

- Pathway: 510(k) (Special)
- Applicant: Conceivex, Inc.
- Decided: May 14, 2008 after 58 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 K942697 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050828: Trojan Supra Lubricated Polyurethane Male Condom, Church & Dwight Co., Inc. (2006) Summary page 1.
- K063227: Conceivex Conception Kit, Conceivex, Inc. (2007) Summary page 1.
- (no number) Sagami condom: named in the summary without a submission number
- (no number) Avanti Semen Collection device: named in the summary without a submission number

## Indications for use
The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

Source page: https://510kreport.com/device/K080752
Methodology: https://510kreport.com/methodology