# K020292: Uterine Injector

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Research, Inc.
- Decided: Apr 17, 2002 after 79 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K032835: H/S Catheter Set (2003), 7 descendants of its own
- K123258: The Advance Catheter for HSG and Sis (2013), 3 descendants of its own
- K092579: Intrauterine Insemination (Iui) Catheter (2010), 2 descendants of its own
- K160217: uVue HSG/SHG Catheter (2016), 1 descendant of its own
- K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (2019), 0 descendants of its own

## Recalls of this device
- Apr 24, 2006 · Not classified · Z-1077-06: The uterine stop component was not included with the device.

## Indications for use
To be used during hysterosalpingograms, salpingoplasties, and hydrotubation.

Source page: https://510kreport.com/device/K020292
Methodology: https://510kreport.com/methodology