# K092579: Intrauterine Insemination (Iui) Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Fertiligent, Ltd.
- Decided: Apr 2, 2010 after 228 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: 3 generations back to K953034 (1995). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032835: H/S Catheter Set, Catheter Research, Inc. (2003) Summary page 1.

## Most influential descendants
- K141666: Fertiligent Slow Release Iui Catheter Kit (2015), 0 descendants of its own
- K120154: Intrauterine Insemination (Iui) Catheter (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K092579
Methodology: https://510kreport.com/methodology