Set, Dialyzer Holder
The Dialyzer Holder Set is a component used within hemodialysis systems to secure and position the dialyzer during treatment, ensuring proper blood and dialysate flow paths. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKI, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- FKI
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K843504 | AMER. BENTLEY HEMOFILTER HOLDER HFH-1 | Oct 18, 1984 | Substantially Equivalent | American Bentley |
| K811292 | PARALLEL PLATE DIALYZER HOLDER | Jun 02, 1981 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K802075 | HOLLOW FIBER DIALYZER HOLDER | Sep 16, 1980 | Substantially Equivalent | Renal Devices, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.