510(k) · Cleared
ClearedCytosponge Cell Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Nov 26, 2014 as substantially equivalent to K934193 (Biosearch Medical Products, Inc., 1993) and 1 other predicate after a 65-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 65 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934193 (1993). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK934193 Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystBiosearch Medical Products, Inc. · 1993
- This deviceK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- Descendant · cites it directly · 3 of its ownK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK181020 Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK233142 EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024
- Descendant · cites it directly · 0 of its ownK203450 EsophaCap Swallowable Cellular Retrieval Device (changed from…Capnostics, LLC · 2021 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K152794Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · cites it directly3descendants
- K181020Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · cites it directly2descendants
- K233142EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024 · 2 generations on0descendants
- K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | 1993 | — |
| 0 (this device) | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| +1 | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | 2 |
| +1 | K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018 | 1 |
| +2 | K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024 | — |
| +1 | K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 7.8 · 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? (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 |
|---|---|---|---|
| * | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystSummary page 6…Page 2 of 3 Predicate Devices Primary Predicate: Cell-Mate Mass Cytology Cellular Retrieval System (K934193) Reference Predicate: US Endoscopy Cytology Brush (K103437) Device Description The subject device the Cytosponge™ Cell Col… | 1993 |
| * | K103437 | US Endoscopy Cytology BrushSummary page 6…of 3 Predicate Devices Primary Predicate: Cell-Mate Mass Cytology Cellular Retrieval System (K934193) Reference Predicate: US Endoscopy Cytology Brush (K103437) Device Description The subject device the Cytosponge™ Cell Collection Device is a sterile single-use device. The Cytosponge™ Ce… | 2010 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142695: Cytosponge Cell 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/K142695
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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