# K980061: Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Mar 2, 1998 after 54 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 K870551 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894264: KDF-2.3, Unimar, Inc. (1989) Summary page 1.
- K870551: Intrauterine Insemination Catheter, Cook Ob/Gyn (1987) Summary page 1.
- K931630: Insemi-Cath, Cook Ob/Gyn (1994) Summary page 1.
- (no number) Insemination Cannula manufactured by Milex: named in the summary without a submission number

## Indications for use
EMBRYON® Intra-uterine Insemination Catheters are purpose designed for the introduction of washed spermatazoa into the uterus,

Source page: https://510kreport.com/device/K980061
Methodology: https://510kreport.com/methodology