510(k) · Cleared
Recalled · Class II · 2024EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capnostics, LLC · EOX Esophagoscope (Flexible Or Rigid)
Cleared on May 4, 2021 as substantially equivalent to K934193 (Biosearch Medical Products, Inc., 1993) and 3 other predicates after a 162-day review. Its family tree reaches back 4 generations to 1993. It has been recalled 2 times.
- Decided
- May 4, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- EOX
- Recalls
- 2
- Predicates
- 4
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 deviceK203450 EsophaCap Swallowable Cellular Retrieval Device (changed from…Capnostics, LLC · 2021
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) | K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021 | — |
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 7.8 · 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? (4)
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 4…OX Device Panel: Ear, Nose and Throat Devices Device Classification: Class II Legally Marketed Predicate Devices for Claimed Equivalency: a) K934193: Cell-MateTM Mass Cytology -Cellular Retrieval System b) K142695, K152794 and K181020: Cytosponge TM… | 1993 |
| * | K142695 | Cytosponge Cell Collection DeviceSummary page 4…ification: Class II Legally Marketed Predicate Devices for Claimed Equivalency: a) K934193: Cell-MateTM Mass Cytology -Cellular Retrieval System b) K142695, K152794 and K181020: Cytosponge TM Cell Collection Device… | 2014 |
| * | K152794 | Cytosponge Cell Collection DeviceSummary page 4…: Class II Legally Marketed Predicate Devices for Claimed Equivalency: a) K934193: Cell-MateTM Mass Cytology -Cellular Retrieval System b) K142695, K152794 and K181020: Cytosponge TM Cell Collection Device Not… | 2016 |
| * | K181020 | Cytosponge Cell Collection DeviceSummary page 4…Legally Marketed Predicate Devices for Claimed Equivalency: a) K934193: Cell-MateTM Mass Cytology -Cellular Retrieval System b) K142695, K152794 and K181020: Cytosponge TM Cell Collection Device Note: The CytoS… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2024 | Class II | Z-1900-2024 | Under Investigation by firm | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter… |
| Apr 24, 2024 | Class II | Z-1899-2024 | Under Investigation by firm | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K934193.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203450: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203450
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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