# K232579: Twoplus Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Hannah Life Technologies Pte, Ltd.
- Decided: Dec 21, 2023 after 118 days
- Product code: QYZ (At Home Intravaginal Insemination System)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the delivery of semen into the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.

Source page: https://510kreport.com/device/K232579
Methodology: https://510kreport.com/methodology