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 18, 2021 as substantially equivalent to K183262 (Lucid Diagnostics, Inc., 2019) after a 30-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 18, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911588 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911588 Brandt Esophageal Cytology BalloonWilson-Cook Medical, Inc. · 1992
- 1 generation backK183262 EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. · 2019
- This deviceK210137 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK222366 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK230339 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −2 | K911588 | Brandt Esophageal Cytology Balloon | Wilson-Cook Medical, Inc. | 1992 | — |
| −1 | K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019 | — |
| 0 (this device) | K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021 | — |
| +1 | K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022 | — |
| +2 | K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K183262 | EsoCheck CCD Cell Collection DeviceSummary page 4…Esophagoscope (flexible or rigid) and accessories 21 CFR 874.4710, Class II, Product Code EOX Predicate Devices EsoCheck CCD Cell Collection Device (K183262) Intended Use The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface c… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222366 | EsoCheck Cell Collection Device | 2022 | 1 |
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 29 years and passes through 2 companies; a new generation was cleared every 26.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222366 (Lucid Diagnostics, Inc., 2022) has gone furthest, with 1 descendant 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. 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 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, 22 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210137: 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/K210137
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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