# K141666: Fertiligent Slow Release Iui Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Fertiligent, Ltd.
- Decided: Feb 3, 2015 after 225 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: 4 generations back to K953034 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092579: Intrauterine Insemination (Iui) Catheter, Fertiligent, Ltd. (2010) Summary page 4.

## Indications for use
Delivery of approximately 1ml of sperm into the uterus over 3-4 hours using a controlled release pump.

Source page: https://510kreport.com/device/K141666
Methodology: https://510kreport.com/methodology