# K982628: Medworks Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medworks Corp.
- Decided: Aug 21, 1998 after 24 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: 2 generations back to K910577 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K884696: Resubmitted Artificial Insemination Instrument Set, Laboratoire Ccd C/O Washington Regulatory Services (1989) Summary page 1.
- K972823: Mini-Embryon Intra Uterine Insemination Catheter, A & A Medical, Inc. (1997) Summary page 1.
- K914150: Jansen-Anderson Insemination Set, Cook Ob/Gyn (1992) Summary page 1.

## Most influential descendants
- K021438: Insemination Catheter, Model 320301 (2002), 0 descendants of its own

## Indications for use
For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Source page: https://510kreport.com/device/K982628
Methodology: https://510kreport.com/methodology