FDA product code FKT: System, Dialysate Delivery, Sorbent Regenerated
FKT is the FDA product code for system, dialysate delivery, sorbent regenerated. It is a Class II device, regulated under 21 CFR 876.5600 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 19 510(k) submissions under FKT, from 4 different applicants. The average 510(k) review took 109 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Sorbent Regenerated |
| Device class | Class II |
| Regulation | 21 CFR 876.5600 |
| 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 FKT clearance
Top FKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Organon Teknika Corp. | 9 | 1988-10-25 |
| Renal Solutions, Inc. | 6 | 2013-02-15 |
| Ash Medical Systems, Inc. | 3 | 1988-04-08 |
| Gambro Healthcare | 1 | 1996-08-28 |
Most recent FKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123835 | Renal Solutions, Inc. | 2008 HEMODIALYSIS SORBENT SYSTEM | 2013-02-15 | 64 |
| K093362 | Renal Solutions, Inc. | 2008 HEMODIALYSIS SORBENT SYSTEM | 2010-08-13 | 289 |
| K070739 | Renal Solutions, Inc. | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | 2007-05-25 | 70 |
| K060381 | Renal Solutions, Inc. | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | 2006-05-24 | 99 |
| K043574 | Renal Solutions, Inc. | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | 2005-06-03 | 158 |
Recalls for FKT devices
openFDA lists no recalls for product code FKT.
Frequently asked questions
What is FDA product code FKT?
FKT is the FDA product code for system, dialysate delivery, sorbent regenerated. It is a Class II device, regulated under 21 CFR 876.5600 and reviewed by the Gastroenterology and Urology panel.
What device class is FKT?
Class II, regulation 21 CFR 876.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKT?
Across 19 cleared submissions the average was 109 days from receipt to decision (median 86).
Which companies have the most FKT clearances?
Organon Teknika Corp. (9); Renal Solutions, Inc. (6); Ash Medical Systems, Inc. (3); Gambro Healthcare (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKT
- Run a recall and safety report across every FKT manufacturer
- Watch product code FKT 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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