FDA product code FKJ: Filter, Blood, Dialysis
FKJ is the FDA product code for filter, blood, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FKJ, 1 in the last five years, from 5 different applicants. The average 510(k) review took 81 days (median 78); 104 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Blood, Dialysis |
| 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 |
510(k) clearances per year for FKJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 104 |
Compare with all 510(k) review times · Search every FKJ clearance
Top FKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Serim Research | 1 | 2026-03-17 |
| Serim Research Corp. | 1 | 1990-09-13 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1984-05-14 |
| Computer Dialysis Systems, Inc. | 1 | 1982-05-20 |
| Terumo America, Inc. | 1 | 1977-11-28 |
Most recent FKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253863 | Serim Research | GUARDIAN Quick Dip Residual Chlorine (5212) | 2026-03-17 | 104 |
| K901734 | Serim Research Corp. | SERIM RESIDUAL CHLORINE TEST KIT | 1990-09-13 | 149 |
| K841307 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBL GASPAK POUCH | 1984-05-14 | 45 |
| K820575 | Computer Dialysis Systems, Inc. | J.E.T. DIALYSIS SYSTEM | 1982-05-20 | 78 |
| K772040 | Terumo America, Inc. | TRANSDUCER PROTECTOR | 1977-11-28 | 31 |
Recalls for FKJ devices
openFDA lists no recalls for product code FKJ.
Frequently asked questions
What is FDA product code FKJ?
FKJ is the FDA product code for filter, blood, dialysis. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKJ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKJ?
Across 5 cleared submissions the average was 81 days from receipt to decision (median 78).
Which companies have the most FKJ clearances?
Serim Research (1); Serim Research Corp. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Computer Dialysis Systems, Inc. (1); Terumo America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKJ
- Run a recall and safety report across every FKJ manufacturer
- Watch product code FKJ 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times