# K053208: Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Swemed Lab International AB
- Decided: Jan 30, 2006 after 75 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: 2 generations back to K990350 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990350: Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316, CooperSurgical, Inc. (1999) Summary page 1.
- K023379: Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction Catheter, Cooper Surgical (2002) Summary page 1.
- K990348: Wallace Trial Transfer Catheter, Model TT 1816N, CooperSurgical, Inc. (1999) Summary page 2.
- K023384: Coopersurgical Trial Transfer Catheter, Cooper Surgical (2002) Summary page 2.
- K990349: Wallace Malleable Stylet-18CM, Model 1816ST, Wallace Malleable Stylet-23CM, Model 1816NST, CooperSurgical, Inc. (1999) Summary page 2.
- K023382: Coopersurgical Malleable Sytlet, Cooper Surgical (2002) Summary page 2.

## Indications for use
The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity. The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer. The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.

Source page: https://510kreport.com/device/K053208
Methodology: https://510kreport.com/methodology