FDA product code FJG: Dialyzer, Parallel Flow
FJG is the FDA product code for dialyzer, parallel flow. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 36 510(k) submissions under FJG, from 15 different applicants. The average 510(k) review took 91 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, Parallel Flow |
| 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 FJG clearance
Top FJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gambro, Inc. | 7 | 1986-09-29 |
| Cobe Laboratories, Inc. | 4 | 1982-03-31 |
| Extracorporeal Medical Specialities, Inc. | 4 | 1981-06-12 |
| Hospal Medical Corp. | 4 | 1979-08-07 |
| Cyberex Corp. | 3 | 1981-05-05 |
10 more applicants have FJG clearances. See the full list in Caduvo.
Most recent FJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933681 | Cobe Renal Care, Inc. | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | 1994-09-07 | 405 |
| K933680 | Cobe Renal Care, Inc. | GAMBRO LUNDIA PRO 200 DIALYZER | 1994-08-26 | 393 |
| K920693 | National Medical Care, Medical Products Div., Inc. | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | 1992-09-21 | 220 |
| K915504 | C.G.H. Medical, Inc. | GAMBRO LUNDIA ALPHA HEMODIALYZERS | 1992-03-06 | 88 |
| K901368 | Gambro-Hospal, Inc. | HEMOSPAL KITS A1, A2D, AO, & A1D | 1990-08-02 | 132 |
Recalls for FJG devices
openFDA lists no recalls for product code FJG.
Frequently asked questions
What is FDA product code FJG?
FJG is the FDA product code for dialyzer, parallel flow. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJG?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJG?
Across 36 cleared submissions the average was 91 days from receipt to decision (median 63).
Which companies have the most FJG clearances?
Gambro, Inc. (7); Cobe Laboratories, Inc. (4); Extracorporeal Medical Specialities, Inc. (4); Hospal Medical Corp. (4); Cyberex Corp. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code FJG
- Run a recall and safety report across every FJG manufacturer
- Watch product code FJG 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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