Filter, Blood, Dialysis
The Dialysis Blood Filter is a component used in hemodialysis circuits to remove particulates or emboli from the patient's blood as it passes through the extracorporeal circuit. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKJ, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.
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Basic Information
- Product Code
- FKJ
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) | Mar 17, 2026 | Substantially Equivalent | Serim Research |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Sep 13, 1990 | Substantially Equivalent | Serim Research Corp. |
| K841307 | BBL GASPAK POUCH | May 14, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K820575 | J.E.T. DIALYSIS SYSTEM | May 20, 1982 | Substantially Equivalent | Computer Dialysis Systems, Inc. |
| K772040 | TRANSDUCER PROTECTOR | Nov 28, 1977 | Substantially Equivalent | Terumo America, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.