510(k) · Decided
DecidedEsoCheck Cell Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lucid Diagnostics, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Feb 24, 2023 as substantially equivalent to K222366 (Lucid Diagnostics, Inc., 2022) after a 17-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Feb 24, 2023
- Review
- 17 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911588 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK911588 Brandt Esophageal Cytology BalloonWilson-Cook Medical, Inc. · 1992
- 3 generations backK183262 EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. · 2019
- 2 generations backK210137 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2021
- 1 generation backK222366 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2022
- This deviceK230339 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911588 | Brandt Esophageal Cytology Balloon | Wilson-Cook Medical, Inc. | 1992 | — |
| −3 | K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019 | — |
| −2 | K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021 | — |
| −1 | K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022 | — |
| 0 (this device) | K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K222366 | EsoCheck Cell Collection DeviceSummary page 4…pe (flexible or rigid) and accessories 21 CFR 874.4710, Class II, Product Code EOX Predicate Device EsoCheck Cell Collection Device (K222366) Reference Device EsophaCap@ Swallowable Cellular Retrieval Device (K203450) Intended Use / Indications for Use… | 2022 |
| † | K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.
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/K230339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230339: EsoCheck 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/K230339
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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