# K041470: Morton Iui Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Fertility Technology Resources, Inc.
- Decided: Nov 22, 2004 after 173 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 13, 2007 · Not classified · Z-0663-2008: Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

## Indications for use
Insemination Catheters are used for transferring spermatozoa into the uterine cavity.

Source page: https://510kreport.com/device/K041470
Methodology: https://510kreport.com/methodology