510(k) · Cleared
ClearedDigene Cervical Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digene Corp. · HHT Spatula, Cervical, Cytological
Cleared on Sep 19, 1997 as substantially equivalent to K832986 (Donald G. Zeller, 1984) after a 141-day review. Its family tree reaches back 1 generation to 1984. 7 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 141 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832986 (1984). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK832986 Pap Smear BrushDonald G. Zeller · 1984
- This deviceK971586 Digene Cervical BrushDigene Corp. · 1997
- Descendant · cites it directly · 3 of its ownK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- Descendant · 2 generations on · 1 of its ownK050889 Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK013258 Inpath E2 CollectorMolecular Diagnostics · 2002
- Descendant · 2 generations on · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · 2 generations on · 0 of its ownK072381 Softpap Cervical Cell CollectorCytocore, Inc. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000 · cites it directly3descendants
- K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005 · 2 generations on1descendant
- K013258Inpath E2 CollectorMolecular Diagnostics · 2002 · cites it directly1descendant
- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · 2 generations on1descendant
- K072381Softpap Cervical Cell CollectorCytocore, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832986 | Pap Smear Brush | Donald G. Zeller | 1984 | — |
| 0 (this device) | K971586 | Digene Cervical Brush | Digene Corp. | 1997 | — |
| +1 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| +2 | K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | 2005 | — |
| +1 | K013258 | Inpath E2 Collector | Molecular Diagnostics | 2002 | — |
| +2 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +2 | K072381 | Softpap Cervical Cell Collector | Cytocore, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 HHT? 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 |
|---|---|---|---|
| * | K832986 | Pap Smear BrushSummary page 2…ual Name Specimen (cervical) collection brush Classification Name Spatula, cervical, cytological 000020 KA 155 fr Predicate Device Medscand Cytobrush (K832986) Device Description The Digene Cervical Brush has a truncated cone-shaped brush head composed of bristles joined to a wire shaf… | 1984 |
What descends from it? (7)
3 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?
How does its category compare?
All HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · HHT
Too few HHT 510(k)s in any year since 2007 to give a median.
Recalls per year · HHT
No recall names HHT since 2007.
Adverse event reports per year · HHT
1in 2025
MAUDE reports naming product code HHT, 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 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Digene Cervical Brush is intended for the collection of cervical
cells for Pap smear analysis and/or for sexually transmitted disease
(STD) testing.
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/K971586 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971586: Digene Cervical Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971586
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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