FDA product code QIS: Esophageal, Mucosal, Electrical Characterization
QIS is the FDA product code for esophageal, mucosal, electrical characterization. It is a Class II device, regulated under 21 CFR 876.1450 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QIS, 2 in the last five years, from 2 different applicants. The average 510(k) review took 186 days (median 186); 266 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Classification
| Field | Value |
|---|---|
| Device name | Esophageal, Mucosal, Electrical Characterization |
| Device class | Class II |
| Regulation | 21 CFR 876.1450 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QIS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 106 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every QIS clearance
Top QIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alandra Medical Sapi DE CV | 1 | 2024-09-06 |
| Diversatek Healthcare | 1 | 2023-04-25 |
Most recent QIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233974 | Alandra Medical Sapi DE CV | Mucosal Impedance Measurement System | 2024-09-06 | 266 |
| K230056 | Diversatek Healthcare | MiVu Esophageal Endo Cap | 2023-04-25 | 106 |
Recalls for QIS devices
openFDA lists no recalls for product code QIS.
Frequently asked questions
What is FDA product code QIS?
QIS is the FDA product code for esophageal, mucosal, electrical characterization. It is a Class II device, regulated under 21 CFR 876.1450 and reviewed by the Gastroenterology and Urology panel.
What device class is QIS?
Class II, regulation 21 CFR 876.1450. Typical premarket route: 510(k).
How long does a 510(k) take for product code QIS?
Across 2 cleared submissions the average was 186 days from receipt to decision (median 186).
Which companies have the most QIS clearances?
Alandra Medical Sapi DE CV (1); Diversatek Healthcare (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QIS
- Run a recall and safety report across every QIS manufacturer
- Watch product code QIS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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