# K162878: Kitazato ET Catheters - Pathway: 510(k) (Traditional) - Applicant: Kitazato Corporation - Decided: Jul 13, 2017 after 272 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 K983594 (1998). 4 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 7 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter, Portex, Ltd. (2003) Summary page 5. ## Most influential descendants - 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 ## Indications for use The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilisation. Kitazato ET Catheters are provided in various configurations (Type 1 through Type 5), which consist of the following components: • Transfer Catheter, for delivery of embryos into the uterine cavity; • Guide Catheter, to guide the insertion of the Transfer Catheter and reinforce it during use: • Trial Catheter, used to confirm the curvature of the cervix and if the cervix is passable; • Stylet Sheath, used to increase the strength of the Guide Catheter during insertion. Source page: https://510kreport.com/device/K162878 Methodology: https://510kreport.com/methodology