Product Code: FHS
FDA class 2
21 CFR 876.5820
Dialyzer, Single Coil
Gastroenterology, Urology
The Single Coil Dialyzer is a hemodialysis device in which blood flows through a coiled semipermeable membrane immersed in dialysate solution, allowing diffusion of waste products from the blood during renal replacement therapy. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FHS, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty. This device is considered life-sustaining or life-supporting.
510(k)s
12
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
5
Basic Information
- Product Code
- FHS
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812811 | MICROCOIL 80 DIALYZER | Dec 03, 1981 | Substantially Equivalent | Erika, Inc. |
| K811974 | MICROCOIL 150 DIALYZER | Sep 16, 1981 | Substantially Equivalent | Erika, Inc. |
| K801634 | THE VITA 2 DISPOSABLE DIALYZER | Dec 17, 1980 | Substantially Equivalent | Bellco Artifidial Organ Spec., Inc. |
| K800723 | MICRO-COIL 100 COIL DIALYZER | May 14, 1980 | Substantially Equivalent | Erika, Inc. |
| K800174 | GAMBRO LUNDIA COIL DIALYZER | Feb 13, 1980 | Substantially Equivalent | Gambro, Inc. |
| K790223 | DIALYZER, CD-800 COIL | Mar 26, 1979 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K781102 | DIALYZER, DISP., COIL, LUNDIA | Oct 17, 1978 | Substantially Equivalent | Gambro, Inc. |
| K771349 | MODIFICATION TO KIDNEY DIALYZER | Aug 02, 1977 | Substantially Equivalent | Erika, Inc. |
| K770735 | DIALYZER, COIL, CD, LSA, 5M1765 | May 10, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K761358 | COIL DIALYZER MODEL ALT 140 | Jan 10, 1977 | Substantially Equivalent | Bentley Laboratories, Inc. |
| K760702 | ERI-FLO 900 DIALYZER | Nov 19, 1976 | Substantially Equivalent | Erika, Inc. |
| K760374 | DIALYZER (MODEL 1850) | Oct 27, 1976 | Substantially Equivalent | Erika, Inc. |