# K021438: Insemination Catheter, Model 320301

- Pathway: 510(k) (Abbreviated)
- Applicant: Labotect Labor-Technik Gottingen
- Decided: Jul 16, 2002 after 71 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: 3 generations back to K910577 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910577: Edwards-Wallace Bourne Hall Catheter, Marlo Surgical Technology (1991) Summary page 1.
- K972823: Mini-Embryon Intra Uterine Insemination Catheter, A & A Medical, Inc. (1997) Summary page 1.
- K982628: Medworks Insemination Catheter, Medworks Corp. (1998) Summary page 1.
- K914150: Jansen-Anderson Insemination Set, Cook Ob/Gyn (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K830061: Thayer-Martin, Modified, bioMerieux, Inc. (1983). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The catheter is used for intrauterine insemination.

Source page: https://510kreport.com/device/K021438
Methodology: https://510kreport.com/methodology