510(k) · Cleared
ClearedPap Smear Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Donald G. Zeller · HHT Spatula, Cervical, Cytological
Cleared on Feb 10, 1984 after a 162-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 10, 1984
- Review
- 162 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK832986 Pap Smear BrushDonald G. Zeller · 1984
- Descendant · cites it directly · 7 of its ownK971586 Digene Cervical BrushDigene Corp. · 1997
- Descendant · 2 generations on · 3 of its ownK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- Descendant · 3 generations on · 1 of its ownK050889 Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK013258 Inpath E2 CollectorMolecular Diagnostics · 2002
- Descendant · 3 generations on · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K971586Digene Cervical BrushDigene Corp. · 1997 · cites it directly7descendants
- K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000 · 2 generations on3descendants
- K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005 · 3 generations on1descendant
- K013258Inpath E2 CollectorMolecular Diagnostics · 2002 · 2 generations on1descendant
- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K832986 | Pap Smear Brush | Donald G. Zeller | 1984 | — |
| +1 | K971586 | Digene Cervical Brush | Digene Corp. | 1997 | — |
| +2 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| +3 | K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | 2005 | — |
| +2 | K013258 | Inpath E2 Collector | Molecular Diagnostics | 2002 | — |
| +3 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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, K971586 (Digene Corp., 1997) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K832986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K832986: Pap Smear Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832986
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026