De Novo · Granted
GrantedMucosal Integrity Conductivity (MI) Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diversatek Healthcare, Inc. · QIS Esophageal, Mucosal, Electrical Characterization
Granted on Dec 23, 2019 as a new device type through De Novo after a 371-day review. 2 later devices descend from it.
- Decided
- Dec 23, 2019
- Review
- 371 days
- Class
- Class II
- Product code
- QIS
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN180067 Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK233974 Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV · 2024
- Descendant · cites it directly · 0 of its ownK230056 MiVu™ Esophageal Endo CapDiversatek Healthcare · 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 |
|---|---|---|---|---|---|
| 0 (this device) | DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Diversatek Healthcare, Inc. | 2019 | — |
| +1 | K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024 | — |
| +1 | K230056 | MiVu™ Esophageal Endo Cap | Diversatek Healthcare | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
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, K233974 (Alandra Medical Sapi DE CV, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIS devicesQIS Esophageal, Mucosal, Electrical Characterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. 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/DEN180067 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180067: Mucosal Integrity Conductivity (MI) Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180067
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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