# K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Dec 19, 2003 after 81 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983594 (1998). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 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.
- K990348: Wallace Trial Transfer Catheter, Model TT 1816N, CooperSurgical, Inc. (1999) Summary page 1.
- K983594: Embryo Transfer Catheters/Sets, Cook Ob/Gyn (1998) Summary page 1.

## Most influential descendants
- K162878: Kitazato ET Catheters (2017), 2 descendants of its own
- K253354: Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (2026), 0 descendants of its own
- K243373: Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (2025), 0 descendants of its own
- K161547: Transem and EchoGen Embryo Transfer Catheters (2017), 0 descendants of its own
- K162064: CrossBay IVF Embryo Transfer Catheter Set (2017), 0 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1241-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1239-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1243-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1240-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1244-2013: Unable to pass catheter through outer sheath during embryo transfer
- Mar 28, 2013 · Class II · Z-1242-2013: Unable to pass catheter through outer sheath during embryo transfer

## Indications for use
Embryo Replacement Catheters are sterile, single-use devices for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation. Trial Transfer Catheters are sterile, single-use devices for determining whether the cervix is passable for a Wallace embryo replacement catheter

Source page: https://510kreport.com/device/K033084
Methodology: https://510kreport.com/methodology