# K091287: VS-Sense Test

- Pathway: 510(k) (Traditional)
- Applicant: Common Sense, Ltd.
- Decided: Aug 31, 2009 after 122 days
- Product code: CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative))
- 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The VS-SENSETM TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.

Source page: https://510kreport.com/device/K091287
Methodology: https://510kreport.com/methodology