# K231730: FemaSeed Intratubal Insemination

- Pathway: 510(k) (Traditional)
- Applicant: Femasys, Inc.
- Decided: Sep 22, 2023 after 101 days
- Product code: MQF (Catheter, Assisted Reproduction)
- 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: 1 generation back to K983591 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983591: Intratubal Transfer Sets, Cook Ob/Gyn (1998) Summary page 4.

## Indications for use
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance

Source page: https://510kreport.com/device/K231730
Methodology: https://510kreport.com/methodology