# K140186: The Stork Otc

- Pathway: 510(k) (Traditional)
- Applicant: Rinovum Women'S Health, Inc.
- Decided: Jul 11, 2014 after 168 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: 3 generations back to K902936 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112200: Focus Touch Conception System, Intimate Bridge 2 Conception, Inc. (2012) Summary page 1.

## Indications for use
The Stork® OTC is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Stork® OTC contains a cervical cap inside a condom-like silicone sheath. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork® OTC should be used during the ovulatory phase of the menstrual cycle. The Stork® OTC Cervical Cap should not be left in place for longer than six hours.

Source page: https://510kreport.com/device/K140186
Methodology: https://510kreport.com/methodology