510(k) · Cleared
ClearedKolplast Cervical Sample Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kolplast CI SA · HHT Spatula, Cervical, Cytological
Cleared on Jan 13, 2017 as substantially equivalent to K861389 (Intl. Cytobrush, Inc., 1986) after a 442-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jan 13, 2017
- Review
- 442 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861389 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK861389 Pap Smear KitIntl. Cytobrush, Inc. · 1986
- This deviceK153128 Kolplast Cervical Sample Collection KitKolplast CI SA · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861389 | Pap Smear Kit | Intl. Cytobrush, Inc. | 1986 | — |
| 0 (this device) | K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | 2017 | — |
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 |
|---|---|---|---|
| * | K861389 | Pap Smear KitSummary page 4…ual Instrument Regulation Number: 21 CFR 884.4530 Product Code: HHT Device Class: Class II Predicate Devices: Pap Smear Kit (K861389) Device Description: The Kolplast Cervical Sample Collection Kit is composed of the Kolplast Cervical Brush Protected Tip and t… | 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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K861389.
How does its category compare?
All HHT devicesHHT Spatula, Cervical, Cytological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution.
For prescription use only.
It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153128 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153128: Kolplast Cervical Sample Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153128
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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