FDA product code QEB: Ventilatory Electrical Impedance Tomograph
QEB is the FDA product code for ventilatory electrical impedance tomograph. It is a Class II device, regulated under 21 CFR 868.1505 and reviewed by the Anesthesiology panel. FDA has cleared 5 510(k) submissions under QEB, 5 in the last five years, from 3 different applicants. The average 510(k) review took 239 days (median 244); 224 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patients thorax.
Classification
| Field | Value |
|---|---|
| Device name | Ventilatory Electrical Impedance Tomograph |
| Device class | Class II |
| Regulation | 21 CFR 868.1505 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for QEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 265 |
| 2023 | 2 | 242 |
| 2025 | 2 | 224 |
Compare with all 510(k) review times · Search every QEB clearance
Top QEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Timpel S.A. | 3 | 2025-09-10 |
| Sentec AG | 1 | 2025-08-07 |
| Bilab | 1 | 2023-06-30 |
Most recent QEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250464 | Timpel S.A. | Enlight 2100 (TPL-E2103-0) | 2025-09-10 | 204 |
| K243765 | Sentec AG | LuMon(TM) System | 2025-08-07 | 244 |
| K222466 | Bilab | AirTom | 2023-06-30 | 318 |
| K222897 | Timpel S.A. | Enlight 2100 | 2023-03-07 | 165 |
| K211135 | Timpel S.A. | Enlight 2100 | 2022-01-06 | 265 |
Recalls for QEB devices
openFDA lists no recalls for product code QEB.
Frequently asked questions
What is FDA product code QEB?
QEB is the FDA product code for ventilatory electrical impedance tomograph. It is a Class II device, regulated under 21 CFR 868.1505 and reviewed by the Anesthesiology panel.
What device class is QEB?
Class II, regulation 21 CFR 868.1505. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEB?
Across 5 cleared submissions the average was 239 days from receipt to decision (median 244).
Which companies have the most QEB clearances?
Timpel S.A. (3); Sentec AG (1); Bilab (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEB
- Run a recall and safety report across every QEB manufacturer
- Watch product code QEB 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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