# K012230: Phem-Alert

- Pathway: 510(k) (Traditional)
- Applicant: Femtek,Llc.
- Decided: Oct 9, 2001 after 85 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: 2 generations back to K850858 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960648: Phem-Chek, Femtek, Inc. (1996) Summary page 1.

## Most influential descendants
- K032161: Phem-Alert (2003), 0 descendants of its own

## Indications for use
The pHEM-ALERT® test measures vaginal pH (acidity) 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 symptorus 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 penods (penodxc vaginal bleeding). This device is not validated for use in pregnant women.

Source page: https://510kreport.com/device/K012230
Methodology: https://510kreport.com/methodology