510(k) · Cleared
ClearedVS-Sense Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Common Sense, Ltd. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Cleared on Aug 31, 2009 as substantially equivalent to K960648 (Femtek, Inc., 1996) after a 122-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Aug 31, 2009
- Review
- 122 days
- Class
- Class I
- Product code
- CEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850858 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960648 | Phem-ChekSummary page 1…-SENSETM 5.1.2.2. Classification name: Paper, Obstetric pH 5.1.3. Identification of the legally marketed predicate device: PHEM-CHEKTM, 5 10(k) no: K960648 A description of the device: The VS-SENSETM comprises a regular vaginal swab with its tip coated by an indicating polymer. When… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K960648.
How does its category compare?
All CEN devicesCEN Dye-Indicator, Ph (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CEN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · CEN
Too few CEN 510(k)s in any year since 2007 to give a median.
Recalls per year · CEN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEN
1in 2018
MAUDE reports naming product code CEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091287: VS-Sense Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091287
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026