510(k) · Cleared
ClearedFemexam Testcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Litmus Concepts, Inc. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Cleared on Feb 7, 1997 after a 210-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Feb 7, 1997
- Review
- 210 days
- Class
- Class I
- Product code
- CEN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962718 | Femexam Testcard | Litmus Concepts, Inc. | 1997 | — |
| +1 | K040008 | Quickvue Advance PH and Amines GLL Test | Quidel Corp. | 2004 | — |
| +1 | K993732 | Bvblue | Gryphus Diagnostics, LLC | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040008 (Quidel Corp., 2004) has gone furthest, with 0 descendants of its own.
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.
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 FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.
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/K962718 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962718: Femexam Testcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962718
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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