# K052059: Iui Catheter, Model 9057

- Pathway: 510(k) (Abbreviated)
- Applicant: Inntec, Inc.
- Decided: Nov 22, 2005 after 116 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 K921518 (1994). 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)
- K921518: Lifetek Iui Catheter, Lifetek Medical, Inc. (1994) Summary page 1.

## Indications for use
The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.

Source page: https://510kreport.com/device/K052059
Methodology: https://510kreport.com/methodology