# K172321: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Dec 21, 2017 after 142 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- 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 K890301 (1989). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890301: Shepard Intrauterine Insemination Catheter, Cook Ob/Gyn (1989) Summary page 4.
- K902694: Coaxial Catheter Set, Cook Ob/Gyn (1990) Summary page 4.
- K954398: Insemi-Cath II, Cook Urological, Inc. (1995) Summary page 4.

## Most influential descendants
- K231645: PherDal® At-Home Insemination Kit (2023), 0 descendants of its own
- K231203: Mosie Baby Kit (2023), 0 descendants of its own

## Indications for use
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.

Source page: https://510kreport.com/device/K172321
Methodology: https://510kreport.com/methodology