FDA product code QAX: Hemodialyzer With Expanded Solute Removal Profile
QAX is the FDA product code for hemodialyzer with expanded solute removal profile. It is a Class II device, regulated under 21 CFR 876.5862 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QAX, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the middle molecular weight range (0.5 kDa to 60 kDa).
Classification
| Field | Value |
|---|---|
| Device name | Hemodialyzer With Expanded Solute Removal Profile |
| Device class | Class II |
| Regulation | 21 CFR 876.5862 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for QAX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every QAX clearance
Top QAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nipro Medical Corporation | 1 | 2026-07-28 |
Most recent QAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261399 | Nipro Medical Corporation | ELISIO-HX | 2026-07-28 | 90 |
Recalls for QAX devices
openFDA lists no recalls for product code QAX.
Frequently asked questions
What is FDA product code QAX?
QAX is the FDA product code for hemodialyzer with expanded solute removal profile. It is a Class II device, regulated under 21 CFR 876.5862 and reviewed by the Gastroenterology and Urology panel.
What device class is QAX?
Class II, regulation 21 CFR 876.5862. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAX?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QAX clearances?
Nipro Medical Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QAX
- Run a recall and safety report across every QAX manufacturer
- Watch product code QAX 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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