510(k) · Cleared
ClearedCervex-Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rovers B.V. · HHT Spatula, Cervical, Cytological
Cleared on May 24, 1994 after a 455-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 24, 1994
- Review
- 455 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK930955 Cervex-BrushRovers B.V. · 1994
- Descendant · cites it directly · 1 of its ownK013258 Inpath E2 CollectorMolecular Diagnostics · 2002
- Descendant · cites it directly · 0 of its ownK083012 PapconeOtto Bock Pur Life Science GmbH · 2009
- Descendant · 2 generations on · 0 of its ownK072381 Softpap Cervical Cell CollectorCytocore, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK983181 CytoprepCytoprep Inc. Est. · 1998
Most influential descendants
Showing 4 of 4 · See all- K013258Inpath E2 CollectorMolecular Diagnostics · 2002 · cites it directly1descendant
- K083012PapconeOtto Bock Pur Life Science GmbH · 2009 · cites it directly0descendants
- K072381Softpap Cervical Cell CollectorCytocore, Inc. · 2008 · 2 generations on0descendants
- K983181CytoprepCytoprep Inc. Est. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930955 | Cervex-Brush | Rovers B.V. | 1994 | — |
| +1 | K013258 | Inpath E2 Collector | Molecular Diagnostics | 2002 | — |
| +1 | K083012 | Papcone | Otto Bock Pur Life Science GmbH | 2009 | — |
| +2 | K072381 | Softpap Cervical Cell Collector | Cytocore, Inc. | 2008 | — |
| +1 | K983181 | Cytoprep | Cytoprep Inc. Est. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (4)
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?
- Of its descendants, K013258 (Molecular Diagnostics, 2002) has gone furthest, with 1 descendant 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/K930955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930955: Cervex-Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930955
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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