# K023823: Easycup

- Pathway: 510(k) (Traditional)
- Applicant: Zer Hitech
- Decided: May 22, 2003 after 188 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component, Maxx Orthopedics, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Zer EasyCup is indicated for use for the early detection Of pregnancy toquaiitativei; measure HCG, a placental hormone, in urine. It is intended to be sold over the counter (OTC) and for professional use, and to be used directly by consumers at home, doctor’s offices, laboratories, and hospitals.

Source page: https://510kreport.com/device/K023823
Methodology: https://510kreport.com/methodology