510(k) · Cleared

Cleared

Phem-Chek

K960648510(k) TraditionalCleared May 13, 199689-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, Inc. · LNW Paper, Obstetric Ph

Cleared on May 13, 1996 as substantially equivalent to K850858 (Uro Pharmaceuticals, Inc., 1985) after an 89-day review. Its family tree reaches back 1 generation to 1985. 3 later devices descend from it.

Decided: May 13, 1996
Review: 89 days
Class: Class I
Product code: LNW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K850858 (1985). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK850858 OB-PH - PH Test PaperUro Pharmaceuticals, Inc. · 1985
This deviceK960648 Phem-ChekFemtek, Inc. · 1996
Descendant · cites it directly · 1 of its ownK012230 Phem-AlertFemtek,Llc. · 2001
Descendant · cites it directly · 0 of its ownK091287 VS-Sense TestCommon Sense, Ltd. · 2009
Descendant · 2 generations on · 0 of its ownK032161 Phem-AlertFemtek,Llc. · 2003

Most influential descendants

Showing 3 of 3 · See all

K012230Phem-AlertFemtek,Llc. · 2001 · cites it directly1descendant
K091287VS-Sense TestCommon Sense, Ltd. · 2009 · cites it directly0descendants
K032161Phem-AlertFemtek,Llc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850858	OB-PH - PH Test Paper	Uro Pharmaceuticals, Inc.	1985	—
0 (this device)	K960648	Phem-Chek	Femtek, Inc.	1996	—
+1	K012230	Phem-Alert	Femtek,Llc.	2001	—
+1	K091287	VS-Sense Test	Common Sense, Ltd.	2009	—
+2	K032161	Phem-Alert	Femtek,Llc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2009	1	0

FIG. 1 — Lineage of K960648, 1985–2009Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K850858	OB-PH - PH Test Paper Summary page 2 …Bristol-Myers Squibb Company, was cited and recommended in such publications. PH paper for measuring vaginal pPH has also been the subject of prior 510 (k) Cclearances, K850858 and K850305. It is currently the practice of physicians to press a strip pH paper against the vaginal wall while h»lding it with…	Uro Pharmaceuticals, Inc.	1985	—
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 …rs Squibb Company, was cited and recommended in such publications. PH paper for measuring vaginal pPH has also been the subject of prior 510 (k) Cclearances, K850858 and K850305. It is currently the practice of physicians to press a strip pH paper against the vaginal wall while h»lding it with either the f…

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012230	Phem-Alert	Femtek,Llc.	2001	1
K091287	VS-Sense Test	Common Sense, Ltd.	2009	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?

Its one ancestor has no recall.
Of its descendants, K012230 (Femtek,Llc., 2001) has gone furthest, with 1 descendant of its own.

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-CHEK is intended for checking the pH level of a woman’s vagina.

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/K960648 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960648: Phem-Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960648

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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