510(k) · Cleared
ClearedexCellerator Cervical Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excell Company, LLC · HHT Spatula, Cervical, Cytological
Cleared on Apr 25, 2019 as substantially equivalent to K861389 (Intl. Cytobrush, Inc., 1986) after a 268-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 25, 2019
- Review
- 268 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 deviceK182049 exCellerator Cervical Collection DeviceExcell Company, LLC · 2019
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) | K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | 2019 | — |
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…logic specialized manual instrument) Device Classification: Class II Product Code: HHT Predicate Device: Pap Perfect Plastic Spatula (K861389) Device Description: The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling de… | 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. 2019, 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 ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the
ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from
the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing.
The ExCellerator device must be used with an IVD labeled endocervical brush.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182049: exCellerator Cervical Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182049
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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