FDA product code FIJ: System, Dialysate Delivery, Recirculating, Single Pass
FIJ is the FDA product code for system, dialysate delivery, recirculating, single pass. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FIJ. The average 510(k) review took 12 days (median 12).
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Recirculating, Single Pass |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FIJ clearance
Top FIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Extracorporeal Medical Specialities, Inc. | 1 | 1977-11-28 |
Most recent FIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K772163 | Extracorporeal Medical Specialities, Inc. | DIALYSIS MACHINES DM-346 & 346-1 | 1977-11-28 | 12 |
Recalls for FIJ devices
openFDA lists no recalls for product code FIJ.
Frequently asked questions
What is FDA product code FIJ?
FIJ is the FDA product code for system, dialysate delivery, recirculating, single pass. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIJ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIJ?
Across 1 cleared submissions the average was 12 days from receipt to decision (median 12).
Which companies have the most FIJ clearances?
Extracorporeal Medical Specialities, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIJ
- Run a recall and safety report across every FIJ manufacturer
- Watch product code FIJ 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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