510(k) · Cleared
ClearedBrandt Esophageal Cytology Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Nov 18, 1992 after a 589-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 18, 1992
- Review
- 589 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK911588 Brandt Esophageal Cytology BalloonWilson-Cook Medical, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK183262 EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK210137 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK222366 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK230339 EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK182159 Strome-Blitzer Cytology BalloonAdn International, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K183262EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. · 2019 · cites it directly3descendants
- K210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2021 · 2 generations on2descendants
- K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2022 · 3 generations on1descendant
- K230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc. · 2023 · 4 generations on0descendants
- K182159Strome-Blitzer Cytology BalloonAdn International, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911588 | Brandt Esophageal Cytology Balloon | Wilson-Cook Medical, Inc. | 1992 | — |
| +1 | K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019 | — |
| +2 | K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021 | — |
| +3 | K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022 | — |
| +4 | K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023 | — |
| +1 | K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 has not posted a summary or statement for it, 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, K183262 (Lucid Diagnostics, Inc., 2019) has gone furthest, with 3 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/K911588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911588: Brandt Esophageal Cytology Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911588
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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