FDA product code FJI: Dialyzer, Capillary, Hollow Fiber
FJI is the FDA product code for dialyzer, capillary, hollow fiber. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 131 510(k) submissions under FJI, from 42 different applicants. The average 510(k) review took 127 days (median 74). FDA has posted 7 recalls for FJI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, Capillary, Hollow Fiber |
| 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 FJI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 178 |
Compare with all 510(k) review times · Search every FJI clearance
Top FJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro, Inc. | 10 | 1990-07-27 |
| Baxter Healthcare Corp | 9 | 1998-05-19 |
| National Medical Care, Medical Products Div., Inc. | 9 | 1995-12-22 |
| Erika, Inc. | 8 | 1985-04-03 |
| Cordis Corp. | 8 | 1981-02-19 |
37 more applicants have FJI clearances. See the full list in Caduvo.
Most recent FJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190459 | Fresenius Medical Care Renal Therapies Group, LLC | Hemoflow F3 and F4 Dialyzers | 2019-08-23 | 178 |
| K122952 | Nipro Medical Corporation | NIPRO PUREFLUX-L HEMODIALYZER | 2013-12-04 | 435 |
| K043342 | Gambro Renal Products | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | 2005-05-27 | 172 |
| K010366 | Molded Products, Inc. | DISPOSABLE STORAGE CAP | 2001-11-28 | 294 |
| K011148 | Interpore Cross Intl. | ULTRACONCENTRATOR SYSTEM | 2001-06-13 | 58 |
Recalls for FJI devices
7 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-08-29.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code FJI?
FJI is the FDA product code for dialyzer, capillary, hollow fiber. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJI?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJI?
Across 131 cleared submissions the average was 127 days from receipt to decision (median 74).
Which companies have the most FJI clearances?
Gambro, Inc. (10); Baxter Healthcare Corp (9); National Medical Care, Medical Products Div., Inc. (9); Erika, Inc. (8); Cordis Corp. (8).
Have FJI devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2025-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FJI
- Run a recall and safety report across every FJI manufacturer
- Watch product code FJI 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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