510(k) · Cleared
ClearedDiamics Cercol Cervical Sample Collector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamics, Inc. · HHT Spatula, Cervical, Cytological
Cleared on Mar 16, 2007 as substantially equivalent to K832986 (Donald G. Zeller, 1984) and 1 other predicate after a 207-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Mar 16, 2007
- Review
- 207 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832986 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832986 Pap Smear BrushDonald G. Zeller · 1984
- This deviceK062433 Diamics Cercol Cervical Sample Collector SystemDiamics, Inc. · 2007
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) | K062433 | Diamics Cercol Cervical Sample Collector System | Diamics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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 |
|---|---|---|---|
| * | K832986 | Pap Smear BrushSummary page 1…HHT Predicate Device: MedScand Sample Collection Kit, Cytyc Part # 70124-001, consisting of the Pap Perfect® Plastic Spatula (K832986) and the Cytobrush® Plus GT Gentle Touch (K86t389) Substantially Equivalent To: The Diamics, Inc.… | 1984 |
| * | K861389 | Pap Smear KitSummary page 1…# 70124-001, consisting of the Pap Perfect® Plastic Spatula (K832986) and the Cytobrush6 Plus GT Gentle Touch (K861389) Description of the Device Subject to Premarket Notification: This device consists of a reusable handle and a multi-component… | 1986 |
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.
- 1 other device also cites its predicate K832986.
How does its category compare?
All HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062433: Diamics Cercol Cervical Sample Collector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062433
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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