# K041094: HSG Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque America, Inc.
- Decided: Jun 17, 2004 after 51 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.

## Most influential descendants
- K061679: Wallace Artificial Insemination Catheter (2006), 3 descendants of its own
- K131491: Kitazato Iui Catheter (2013), 1 descendant of its own
- K163318: Soules Intrauterine Insemination Catheter (2017), 0 descendants of its own
- K162667: Kitazato IUI Catheter (2017), 0 descendants of its own

## Indications for use
Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy. HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.

Source page: https://510kreport.com/device/K041094
Methodology: https://510kreport.com/methodology