# K061679: Wallace Artificial Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Oct 13, 2006 after 120 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
Longest line of descent: 3 generations back to K842231 (1984). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842231: Ackrad Hysterosalpingography Set, Ackrad Laboratories (1984) Summary page 3.
- K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007, Ackrad Laboratories (2002) Summary page 3.
- K970492: Intrauterine Insemination and Sonohysterography Catheter, Ackrad Laboratories (1997) Summary page 3.
- K890869: Bard Hysterosalpingography Catheters, C.R. Bard, Inc. (1989) Summary page 3.
- K041094: HSG Catheter Set, Bioteque America, Inc. (2004) Summary page 3.
- K040238: Softseal HSG Catheter, Modern Medical Equipment Mfg., Ltd. (2004) Summary page 3.
- K964848: Wallace Artificial Insemination Catheter - 8CM/18CM, Marlow Surgical Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.

Source page: https://510kreport.com/device/K061679
Methodology: https://510kreport.com/methodology