Set, Perfusion, Kidney, Disposable
A disposable kidney perfusion set is a sterile, single-use assembly of tubing and components used to circulate oxygenated perfusate through a harvested donor kidney to maintain its viability and reduce ischemic injury during the period between procurement and transplantation. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDL is regulated under 21 CFR 876.5880 in the Gastroenterology, Urology medical specialty. No additional special flags apply to this device.
Basic Information
- Product Code
- KDL
- Device Class
- FDA class 2
- Regulation Number
- 876.5880
- 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 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Jan 24, 2025 | Substantially Equivalent | Bridge to Life Ltd |
| K221387 | BEL-GEN Cold Storage Solution | Jun 14, 2022 | Substantially Equivalent | Institut Georges Lopez |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Jun 14, 2022 | Substantially Equivalent | Institut Georges Lopez |
| K211842 | Servator M SALF Solution | Dec 20, 2021 | Substantially Equivalent | S.A.L.F. spa |
| K192408 | Custodiol HTK Solution | Apr 24, 2020 | Substantially Equivalent | Dr. Franz Kohler Chemie GmbH |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | Oct 20, 2017 | Substantially Equivalent | S.A.L.F. spa |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Aug 16, 2013 | Substantially Equivalent | WATERS MEDICAL SYSTEMS, LLC |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Jun 14, 2013 | Substantially Equivalent | WATERS MEDICAL SYSTEMS, LLC |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Mar 11, 2010 | Substantially Equivalent | ORGAN RECOVERY SYSTEMS, INC. |
| K043461 | CUSTODIOL | Feb 28, 2005 | Substantially Equivalent | DR. FRANZ KOHLER CHEMIE GMBH |
| K020924 | CUSTODIOL HTK SOLUTION | Jan 06, 2003 | Substantially Equivalent | DR. FRANZ KOHLER CHEMIE GMBH |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Sep 25, 1997 | Substantially Equivalent | COBE RENAL CARE, INC. |
| K944866 | VIASPAN (BELZER UW - CSS) | Apr 22, 1996 | Substantially Equivalent | THE DUPONT MERCK PHARMACEUTICAL CO. |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | Mar 20, 1990 | Substantially Equivalent | THE DU PONT CO. |
| K891239 | MOP CATHETER | Nov 28, 1989 | Substantially Equivalent | BIVONA MEDICAL TECHNOLOGIES |
| K883782 | BELZER UW-CSS | Apr 20, 1989 | Substantially Equivalent | DU PONT CRITICAL CARE |
| K884609 | EURO-COLLINS SOLUTION SETS | Jan 26, 1989 | Substantially Equivalent | FRESENIUS USA, INC. |
| K780470 | H.P. MEDICAL GRADE SILICONE TUBING | Apr 27, 1978 | Substantially Equivalent | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
| K760922 | PERFUSION TUBING SET | Nov 19, 1976 | Substantially Equivalent | SHILEY, INC. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.