# K191015: Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: May 17, 2019 after 30 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173103: Pivet and Soft-Pass Embryo Transfer Catheter Sets, Cook Incorporated (2018) Summary page 4.

## Indications for use
The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to aid in verifying catheter access and positioning in advance of an embryo transfer procedure.

Source page: https://510kreport.com/device/K191015
Methodology: https://510kreport.com/methodology