# K060128: Clearblue Easy Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Unipath, Ltd.
- Decided: May 25, 2006 after 127 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K142754: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test (2016), 0 descendants of its own

## Indications for use
Clearblue Easy Digital Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

Source page: https://510kreport.com/device/K060128
Methodology: https://510kreport.com/methodology