510(k) · Cleared
ClearedCell-Mate (TM) Mass Cytology-Cellular Retrieval Syst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Nov 19, 1993 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 19, 1993
- Review
- 85 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK934193 Cell-Mate (TM) Mass Cytology-Cellular Retrieval SystBiosearch Medical Products, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK181020 Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · Recalled
- Descendant · 3 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 5 of 5 · See all- K142695Cytosponge Cell Collection DeviceCovidien, LLC · 2014 · cites it directly4descendants
- K152794Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · 2 generations on3descendants
- K181020Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · 2 generations on2descendants
- K233142EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024 · 3 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 |
|---|---|---|---|---|---|
| 0 (this device) | K934193 | Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst | Biosearch Medical Products, Inc. | 1993 | — |
| +1 | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| +2 | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | 2 |
| +2 | K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018 | 1 |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142695 (Covidien, LLC, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K934193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934193: Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934193
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026