# K013536: Emtrac; Delphin; Semtrac 2000 Set

- Pathway: 510(k) (Traditional)
- Applicant: Gynetics Medical Products NV
- Decided: Nov 30, 2001 after 38 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240307: VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (2024), 0 descendants of its own

## Indications for use
The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures. Semtrac Sets are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.

Source page: https://510kreport.com/device/K013536
Methodology: https://510kreport.com/methodology