FDA product code FII: System, Dialysate Delivery, Sealed
FII is the FDA product code for system, dialysate delivery, sealed. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FII, from 4 different applicants. The average 510(k) review took 105 days (median 117). FDA has posted 2 recalls for FII devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Sealed |
| Device class | Class II |
| Regulation | 21 CFR 876.5860 |
| 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 FII clearance
Top FII applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro, Inc. | 2 | 1988-08-24 |
| Nxstage Medical, Inc. | 1 | 2003-07-07 |
| Travenol Laboratories, S.A. | 1 | 1987-10-13 |
| Hospal Medical Corp. | 1 | 1982-10-06 |
Most recent FII clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030470 | Nxstage Medical, Inc. | NXSTAGE SYSTEM ONE | 2003-07-07 | 145 |
| K881270 | Gambro, Inc. | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | 1988-08-24 | 153 |
| K872364 | Travenol Laboratories, S.A. | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | 1987-10-13 | 117 |
| K862716 | Gambro, Inc. | HEMOFILTRATION SYSTEM 10 | 1986-09-09 | 54 |
| K822386 | Hospal Medical Corp. | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | 1982-10-06 | 58 |
Recalls for FII devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-12-14.
Frequently asked questions
What is FDA product code FII?
FII is the FDA product code for system, dialysate delivery, sealed. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel.
What device class is FII?
Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code FII?
Across 5 cleared submissions the average was 105 days from receipt to decision (median 117).
Which companies have the most FII clearances?
Gambro, Inc. (2); Nxstage Medical, Inc. (1); Travenol Laboratories, S.A. (1); Hospal Medical Corp. (1).
Have FII devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2004-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code FII
- Run a recall and safety report across every FII manufacturer
- Watch product code FII 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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