510(k) · Cleared
ClearedPapcone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Pur Life Science GmbH · HHT Spatula, Cervical, Cytological
Cleared on Apr 9, 2009 as substantially equivalent to K930955 (Rovers B.V., 1994) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 9, 2009
- Review
- 182 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930955 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930955 Cervex-BrushRovers B.V. · 1994
- This deviceK083012 PapconeOtto Bock Pur Life Science GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930955 | Cervex-Brush | Rovers B.V. | 1994 | — |
| 0 (this device) | K083012 | Papcone | Otto Bock Pur Life Science GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930955 | Cervex-BrushSummary page 1…one® Common/Usual Name: Cervical Cell Scraper Classification Name: Cervical Cytological Endocervical Brush Predicate Devices Cervex-Brush® (Rovers Medical Devices B.V., K930955) Puritan Foam Tip Swab Model 2197 (Hardwood Products Company LP, K961934) Device Description The PapCone® consists of an axially… | 1994 |
| * | K961934 | Puritan Foam Tip Swab Model 2197Summary page 1…al Cytological Endocervical Brush Predicate Devices Cervex-Brush® (Rovers Medical Devices B.V., K930955) Puritan Foam Tip Swab Model 2197 (Hardwood Products Company LP, K961934) Device Description The PapCone® consists of an axially symmetric polystyrene grip with a round platform carrying a foam cone (P… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K930955.
How does its category compare?
All HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083012: Papcone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083012
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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