FDA product code FJH: Dialyzer, Disposable
FJH is the FDA product code for dialyzer, disposable. It is a Class II device, regulated under 21 CFR 876.5830 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FJH, from 4 different applicants. The average 510(k) review took 101 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer, Disposable |
| Device class | Class II |
| Regulation | 21 CFR 876.5830 |
| 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 FJH clearance
Top FJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Medical Care, Medical Products Div., Inc. | 1 | 1992-09-21 |
| Societe D' Analyses Bio-Pharmaceutiques,Inc. | 1 | 1986-08-07 |
| Trans-National Trade Development Corp. | 1 | 1985-09-20 |
| Travenol Laboratories, S.A. | 1 | 1982-08-12 |
Most recent FJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920697 | National Medical Care, Medical Products Div., Inc. | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | 1992-09-21 | 220 |
| K861646 | Societe D' Analyses Bio-Pharmaceutiques,Inc. | BIO-CARB D16000, D16001, AND D17000 | 1986-08-07 | 99 |
| K852764 | Trans-National Trade Development Corp. | IDECAP DIALYZER | 1985-09-20 | 84 |
| K822395 | Travenol Laboratories, S.A. | CF 1211 CAPILLARY FLOW DIALYZER CODE | 1982-08-12 | 1 |
Recalls for FJH devices
openFDA lists no recalls for product code FJH.
Frequently asked questions
What is FDA product code FJH?
FJH is the FDA product code for dialyzer, disposable. It is a Class II device, regulated under 21 CFR 876.5830 and reviewed by the Gastroenterology and Urology panel.
What device class is FJH?
Class II, regulation 21 CFR 876.5830. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJH?
Across 4 cleared submissions the average was 101 days from receipt to decision (median 92).
Which companies have the most FJH clearances?
National Medical Care, Medical Products Div., Inc. (1); Societe D' Analyses Bio-Pharmaceutiques,Inc. (1); Trans-National Trade Development Corp. (1); Travenol Laboratories, S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJH
- Run a recall and safety report across every FJH manufacturer
- Watch product code FJH 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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