# K231645: PherDal® At-Home Insemination Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pherdal Fertility Science, Inc.
- Decided: Dec 14, 2023 after 192 days
- Product code: QYZ (At Home Intravaginal Insemination System)
- Device class: 2
- Regulation: 21 CFR 884.6110
- 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 K890301 (1989). 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)
- K172321: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters, Cook Incorporated (2017) Summary page 5.

## Indications for use
The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.

Source page: https://510kreport.com/device/K231645
Methodology: https://510kreport.com/methodology