# K960648: Phem-Chek

- Pathway: 510(k) (Traditional)
- Applicant: Femtek, Inc.
- Decided: May 13, 1996 after 89 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: 1 generation back to K850858 (1985). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850858: OB-PH - PH Test Paper, Uro Pharmaceuticals, Inc. (1985) Summary page 2.

## Cited in the summary but kept off the family tree
- K850305: PH paper for measuring vaginal pH. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K012230: Phem-Alert (2001), 1 descendant of its own
- K091287: VS-Sense Test (2009), 0 descendants of its own
- K032161: Phem-Alert (2003), 0 descendants of its own

## Indications for use
The pHEM-CHEK is intended for checking the pH level of a woman’s vagina.

Source page: https://510kreport.com/device/K960648
Methodology: https://510kreport.com/methodology