510(k) · Cleared
Recalled · Class II · 2023Cytosponge 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 Aug 16, 2018 as substantially equivalent to K152794 (Covidien, LLC, 2016) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 16, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- EOX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934193 (1993). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK934193 Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystBiosearch Medical Products, Inc. · 1993
- 2 generations backK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- 1 generation backK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · Recalled
- This deviceK181020 Cytosponge Cell Collection DeviceCovidien, LLC · 2018
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | 1993 | — |
| −2 | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| −1 | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | 2 |
| 0 (this device) | K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152794 | Cytosponge Cell Collection DeviceSummary page 4…t Code: EOX Establishment Registration Number, Owner/Operator Number: Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Predicate Device(s): K152794 Cytosponge™ Cell Collection Device by Covidien llc (Primary predicate) K142695 Cytosponge™ Cell Collection Device by Covidien llc… | 2016 |
| * | K142695 | Cytosponge Cell Collection DeviceSummary page 4…hment Registration Number: 3004904811 Owner/Operator Number: 1282497 Predicate Device(s): K152794 Cytosponge™ Cell Collection Device by Covidien llc (Primary predicate) K142695 Cytosponge™ Cell Collection Device by Covidien llc (Reference predicate) Device Description: The Cytosponge™ Cell Collection Dev… | 2014 |
What descends from it? (2)
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 2, 2023 | Class II | Z-2282-2023 | Process control | Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K233142 (Cyted Limited, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152794.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181020: 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/K181020
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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