Detector, Leak, Blood
The Blood Leak Detector is a safety device incorporated into hemodialysis systems that continuously monitors dialysate for the presence of blood, detecting membrane rupture in the dialyzer and alerting clinicians to stop 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 FJD, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
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Basic Information
- Product Code
- FJD
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123805 | E-Z CHEK BLOOD LEAK TEST STRIPS | Mar 20, 2013 | Substantially Equivalent | Reprocessing Products Corp |
| K042322 | STERICHEK BLOOD LEAK REAGENT STRIPS | Dec 07, 2004 | Substantially Equivalent | Hach Company |
| K012115 | SERIM BLOOD LEAK TEST STRIP-2 | Nov 30, 2001 | Substantially Equivalent | Serim Research Corp. |
| K990206 | SERIM BLOOD LEAK TEST STRIP | Apr 21, 1999 | Substantially Equivalent | Serim Research Corp. |
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.