# K970492: Intrauterine Insemination and Sonohysterography Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ackrad Laboratories
- Decided: Apr 9, 1997 after 58 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
Longest line of descent: 2 generations back to K842231 (1984). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940176: Ackrad Iui Set for Intrauterine Insemination, Ackrad Laboratories (1996) Summary page 1.
- (no number) Goldstein Sonohysterography Catheter: named in the summary without a submission number

## 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

## Recalls of this device
- May 13, 2014 · Class II · Z-1782-2014: Sterility of the device may be compromised due to unsealed pouch

## Indications for use
Injection of saline in the examination of the uterus using ultrasound techniques.

Source page: https://510kreport.com/device/K970492
Methodology: https://510kreport.com/methodology