# K994327: Embryon Transfer Catheters/Sets

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Feb 28, 2000 after 68 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 K983594 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983594: Embryo Transfer Catheters/Sets, Cook Ob/Gyn (1998) Summary page 1.

## Indications for use
The EMBRYON™ Embryo Transfer Catheters / Sets are used to place human embryos into the uterine cavity.

Source page: https://510kreport.com/device/K994327
Methodology: https://510kreport.com/methodology