# K012220: Tao Embryo Transfer Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Ttj Biomedical, LLC
- Decided: Aug 27, 2001 after 42 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Intended Use: Single use, limited exposure (<24 hours), mucosal membrane surface contact, embryo transfer procedures. The Tao embryo transfer catheter system is intended for use for the introduction of embryos into the uterine cavity. The procedure should be completed by an individual with requisite experience and education in the process of IVF and embryo transfers, and the procedure should be completed in a facility suited for IVF and embryo transfers. The catheter system consists of a single use, ETO sterilized inner catheter and outer sleeve.

Source page: https://510kreport.com/device/K012220
Methodology: https://510kreport.com/methodology