FDA product code QAF: Impedance Plethysmograph, Cranial
QAF is the FDA product code for impedance plethysmograph, cranial. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under QAF, 1 in the last five years, from 3 different applicants. The average 510(k) review took 163 days (median 228); 233 days on average over the last three years.
Definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.
Classification
| Field | Value |
|---|---|
| Device name | Impedance Plethysmograph, Cranial |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QAF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 228 |
| 2018 | 1 | 28 |
| 2026 | 1 | 233 |
Compare with all 510(k) review times · Search every QAF clearance
Top QAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stroke DX | 1 | 2026-07-22 |
| Cerebrotech Medical Systems, Inc. | 1 | 2018-11-23 |
| Cerebrotech Medical Systems | 1 | 2017-12-08 |
Most recent QAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253840 | Stroke DX | STEDI Scan Device | 2026-07-22 | 233 |
| K182967 | Cerebrotech Medical Systems, Inc. | Visor System | 2018-11-23 | 28 |
| K171186 | Cerebrotech Medical Systems | Cerebrotech CMS-5000 | 2017-12-08 | 228 |
Recalls for QAF devices
openFDA lists no recalls for product code QAF.
Frequently asked questions
What is FDA product code QAF?
QAF is the FDA product code for impedance plethysmograph, cranial. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Neurology panel.
What device class is QAF?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAF?
Across 3 cleared submissions the average was 163 days from receipt to decision (median 228).
Which companies have the most QAF clearances?
Stroke DX (1); Cerebrotech Medical Systems, Inc. (1); Cerebrotech Medical Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QAF
- Run a recall and safety report across every QAF manufacturer
- Watch product code QAF 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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