# K032161: Phem-Alert

- Pathway: 510(k) (Traditional)
- Applicant: Femtek,Llc.
- Decided: Sep 30, 2003 after 77 days
- Product code: LNW (Paper, Obstetric Ph)
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850858 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012230: Phem-Alert, Femtek,Llc. (2001)

## Indications for use
The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching - Burning - Unpleasant odor - Unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

Source page: https://510kreport.com/device/K032161
Methodology: https://510kreport.com/methodology