510(k) · Cleared

Cleared

Phem-Alert

K012230510(k) TraditionalCleared Oct 9, 200185-day reviewClass I21 CFR 862.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Femtek,Llc. · LNW Paper, Obstetric Ph

Cleared on Oct 9, 2001 as substantially equivalent to K960648 (Femtek, Inc., 1996) after an 85-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.

Decided: Oct 9, 2001
Review: 85 days
Class: Class I
Product code: LNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K850858 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK850858 OB-PH - PH Test PaperUro Pharmaceuticals, Inc. · 1985
1 generation backK960648 Phem-ChekFemtek, Inc. · 1996
This deviceK012230 Phem-AlertFemtek,Llc. · 2001
Descendant · cites it directly · 0 of its ownK032161 Phem-AlertFemtek,Llc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K032161Phem-AlertFemtek,Llc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K850858	OB-PH - PH Test Paper	Uro Pharmaceuticals, Inc.	1985	—
−1	K960648	Phem-Chek	Femtek, Inc.	1996	—
0 (this device)	K012230	Phem-Alert	Femtek,Llc.	2001	—
+1	K032161	Phem-Alert	Femtek,Llc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K012230, 1985–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K960648	Phem-Chek Summary page 1 …rade Name: pHEM-ALERT Common/Usual Name: pH paper Classification Name: “Obstetric pH Paper”, 85LNW, unclassified 3. Legally Marketed Predicate Devices pHEM-ALERT 510(k) K960648 4. Indications for Use / Intended Use The indications and intended uses for the pHEM-ALERT device are: “The pHEM-ALERT® test mc…	Femtek, Inc.	1996	—

Also cleared against K960648: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032161	Phem-Alert	Femtek,Llc.	2003	0

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 16 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K032161 (Femtek,Llc., 2003) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K960648.

How does its category compare?

All LNW devices

LNW 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

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code LNW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012230 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012230: Phem-Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012230

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026