510(k) · Cleared
ClearedMiVu™ Esophageal Endo Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diversatek Healthcare · QIS Esophageal, Mucosal, Electrical Characterization
Cleared on Apr 25, 2023 as substantially equivalent to DEN180067 (Diversatek Healthcare, Inc., 2019) after a 106-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Apr 25, 2023
- Review
- 106 days
- Class
- Class II
- Product code
- QIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180067 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180067 Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. · 2019
- This deviceK230056 MiVu™ Esophageal Endo CapDiversatek Healthcare · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Diversatek Healthcare, Inc. | 2019 | — |
| 0 (this device) | K230056 | MiVu™ Esophageal Endo Cap | Diversatek Healthcare | 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 QIS? 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 QIS device
- #1 K233974 Mucosal Impedance Measurement Systemscore 8.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | DEN180067 | Mucosal Integrity Conductivity (MI) Test SystemSummary page 5…ation Number: 21 CFR 876.1450 Regulatory Class: II 3. Predicate Device Identification Predicate De Novo No.: DEN180067 Predicate Trade Name: MiVu™ Balloon Probe Predicate FDA Product Code: QIS Predicate FDA Classific… | 2019 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN180067.
How does its category compare?
All QIS devicesQIS Esophageal, Mucosal, Electrical Characterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QIS
Too few QIS 510(k)s in any year since 2007 to give a median.
Recalls per year · QIS
No recall names QIS since 2007.
Adverse event reports per year · QIS
No MAUDE report names QIS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230056: MiVu™ Esophageal Endo Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230056
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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