510(k) · Cleared
ClearedEndoSign® Cell collection device (ES-CYT-102)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyted Limited · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Jan 19, 2024 as substantially equivalent to K181020 (Covidien, LLC, 2018) after a 114-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 19, 2024
- Review
- 114 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934193 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK934193 Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystBiosearch Medical Products, Inc. · 1993
- 3 generations backK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- 2 generations backK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · Recalled
- 1 generation backK181020 Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · Recalled
- This deviceK233142 EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | 1993 | — |
| −3 | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| −2 | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | 2 |
| −1 | K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018 | 1 |
| 0 (this device) | K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 EOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOX device
- #1 K222366 EsoCheck Cell Collection Devicescore 7.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K181020 | Cytosponge Cell Collection DeviceSummary page 4…anel: Ear, Nose & Throat Devices Device Regulation: 21 CFR 874.4710, Class II Product Code: EOX Legally Marketed Predicate Device: K181020 CytospongeTM Cell Collection Device by Covidien LLC. Device Description: The EndoSign® Cell collection device is to be used for… | 2018 |
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?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K181020.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · EOX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EOX
Too few EOX 510(k)s in any year since 2007 to give a median.
Recalls per year · EOX
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOX
2in 2024
MAUDE reports naming product code EOX, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EndoSign® Cell collection device is to be used for the collection of cells from the surface of the oesophagus for molecular, cytological and histological analyses.
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/K233142 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233142: EndoSign® Cell collection device (ES-CYT-102).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233142
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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