Product Code: FJH
FDA class 2
21 CFR 876.5830
Dialyzer, Disposable
Gastroenterology, Urology
The Disposable Dialyzer is a single-use hemodialysis membrane device used to filter waste products, excess fluid, and toxins from the blood of patients with renal failure during hemodialysis treatment. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJH, regulated under 21 CFR 876.5830, within the Gastroenterology, Urology specialty.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
10
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Basic Information
- Product Code
- FJH
- Device Class
- FDA class 2
- Regulation Number
- 876.5830
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✓
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | Sep 21, 1992 | Substantially Equivalent | National Medical Care, Medical Products Div., Inc. |
| K861646 | BIO-CARB D16000, D16001, AND D17000 | Aug 07, 1986 | Substantially Equivalent | Societe D' Analyses Bio-Pharmaceutiques,Inc. |
| K852764 | IDECAP DIALYZER | Sep 20, 1985 | Substantially Equivalent | Trans-National Trade Development Corp. |
| K822395 | CF 1211 CAPILLARY FLOW DIALYZER CODE | Aug 12, 1982 | Substantially Equivalent | Travenol Laboratories, S.A. |