510(k) · Cleared
ClearedPhem-Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Femtek,Llc. · LNW Paper, Obstetric Ph
Cleared on Sep 30, 2003 as substantially equivalent to K012230 (Femtek,Llc., 2001) after a 77-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Sep 30, 2003
- Review
- 77 days
- Class
- Class I
- Product code
- LNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 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 LNW? 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 |
|---|---|---|---|
| * | K012230 | Phem-Alert | 2001 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LNW devicesLNW Paper, Obstetric Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNW
FDA has decided no LNW device since 2007.
Median 510(k) review, days · LNW
Too few LNW 510(k)s in any year since 2007 to give a median.
Recalls per year · LNW
No recall names LNW since 2007.
Adverse event reports per year · LNW
1in 2022
MAUDE reports naming product code LNW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032161 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032161: Phem-Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032161
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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