# K940176: Ackrad Iui Set for Intrauterine Insemination

- Pathway: 510(k) (Traditional)
- Applicant: Ackrad Laboratories
- Decided: Apr 23, 1996 after 833 days
- Product code: MFD (Cannula, Intrauterine Insemination)
- Device class: 2
- Regulation: 21 CFR 884.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842231 (1984). 1 ancestor in all.
5 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)
- K842231: Ackrad Hysterosalpingography Set, Ackrad Laboratories (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- K894837: Royal Women’s Coaxial Catheter Set. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K970492: Intrauterine Insemination and Sonohysterography Catheter (1997), 4 descendants of its own
- 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
The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way. The patient population comprises women generally ranging in age from 25 to 45.

Source page: https://510kreport.com/device/K940176
Methodology: https://510kreport.com/methodology