510(k) · Cleared
ClearedEos Brand Disposable Cyto/Cervical Sampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North Eos Industries, Inc. · HHT Spatula, Cervical, Cytological
Cleared on Oct 11, 1996 after a 38-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 11, 1996
- Review
- 38 days
- Class
- Class II
- Product code
- HHT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (10)
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 |
|---|---|---|---|
| * | — | Aver's spatula (wooden) Named without a submission number | |
| * | — | Aver's spatula (plastic) Named without a submission number | |
| * | — | Cyco-Brush Named without a submission number | |
| * | — | cervi-brush Named without a submission number | |
| * | — | Endocarvical sampler Named without a submission number | |
| * | — | Cotton Swab Named without a submission number | |
| * | — | CYeoPick Named without a submission number | |
| * | — | WY noscatin Named without a submission number | |
| * | — | spatulias and cokton Swads (Paul Boettger ong company) Named without a submission number | |
| * | — | veo-spatula for cervical smear Named without a submission number |
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.
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 | — |
What is it indicated for?
The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytoleogical material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963685 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963685: Eos Brand Disposable Cyto/Cervical Sampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026