510(k) · Cleared
Recalled · Class II · 2016Cytosponge 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 Apr 12, 2016 as substantially equivalent to K142695 (Covidien, LLC, 2014) after a 197-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2016
- Review
- 197 days
- Class
- Class II
- Product code
- EOX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934193 (1993). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK934193 Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystBiosearch Medical Products, Inc. · 1993
- 1 generation backK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- This deviceK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016
- 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 3 of 3 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | 1993 | — |
| −1 | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| 0 (this device) | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | — |
| +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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142695 | Cytosponge Cell Collection DeviceSummary page 5…Page 2 of 3 Legally marketed devices to which equivalence is claimed: Cytosponge™ Cell Collection Device (K142695) Reason for 510(k) Submission: The purpose of this 510(k) is to notify the Agency of an… | 2014 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2016 | Class II | Z-2123-2016 | Process control | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus. |
| Jun 6, 2016 | Class II | Z-2122-2016 | Process control | Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 21.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181020 (Covidien, LLC, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K142695.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 for cytological and histological analyses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152794: 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/K152794
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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