Product Code: FJG
FDA class 2
21 CFR 876.5820
Dialyzer, Parallel Flow
Gastroenterology, Urology
The Parallel Flow Dialyzer is a hemodialysis device in which blood and dialysate flow in parallel channels separated by a semipermeable membrane, enabling diffusion of uremic solutes from blood into dialysate during renal replacement therapy. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJG, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
510(k)s
36
FEI Numbers
0
Registration Numbers
0
Unique Applicants
15
Years Active
17
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Basic Information
- Product Code
- FJG
- 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 36 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | Sep 07, 1994 | Substantially Equivalent | Cobe Renal Care, Inc. |
| K933680 | GAMBRO LUNDIA PRO 200 DIALYZER | Aug 26, 1994 | Substantially Equivalent | Cobe Renal Care, Inc. |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | Sep 21, 1992 | Substantially Equivalent | National Medical Care, Medical Products Div., Inc. |
| K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS | Mar 06, 1992 | Substantially Equivalent | C.G.H. Medical, Inc. |
| K901368 | HEMOSPAL KITS A1, A2D, AO, & A1D | Aug 02, 1990 | Substantially Equivalent | Gambro-Hospal, Inc. |
| K902203 | TENCKHOFF PERITONEAL DIALYSIS KIT | Aug 01, 1990 | Unknown | Akcess Medical Products, Inc. |
| K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N | Sep 29, 1986 | Substantially Equivalent | Gambro, Inc. |
| K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER | Jan 08, 1986 | Substantially Equivalent | Gambro, Inc. |
| K820694 | COBE PPD 1.3L, #18-520-009 | Mar 31, 1982 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K812336 | COBE PPD 1.9 | Aug 31, 1981 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K811440 | EXP 600 PARALLEL PLATE DIALYZER | Jun 12, 1981 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K811439 | EXP 200 PARALLEL PLATE DIALYZER | Jun 12, 1981 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K810066 | COBE PPD .8 | Jun 09, 1981 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K810837 | CYBER 80 HEMODIALYZER | May 05, 1981 | Substantially Equivalent | Cyberex Corp. |
| K802478 | CYBER 120 HEMODIALYZER | Mar 20, 1981 | Substantially Equivalent | Cyberex Corp. |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | Mar 04, 1981 | Substantially Equivalent | NIKKISO CO., LTD. |
| K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE | Jan 29, 1981 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K802389 | GAMBRO LUNDIA PLATE DISP. DIALYZER | Dec 22, 1980 | Substantially Equivalent | Gambro, Inc. |
| K801633 | THE BRAVO NEW PARALLEL FLOW DIALYZER | Dec 18, 1980 | Substantially Equivalent | Bellco Artifidial Organ Spec., Inc. |
| K801451 | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM | Sep 26, 1980 | Substantially Equivalent | Medical, Inc. |
| K801377 | CYBER 120 HEMODIALYZER | Aug 27, 1980 | Substantially Equivalent | Cyberex Corp. |
| K800424 | LUNDIA PLATE DISP. | Apr 10, 1980 | Substantially Equivalent | Gambro, Inc. |
| K792611 | GAMBRO LUNDIA PLATE DIALYZER | Feb 06, 1980 | Substantially Equivalent | Gambro, Inc. |
| K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER | Nov 13, 1979 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K791448 | HEMODIALYZERS RP-510 AND RP-514 | Aug 07, 1979 | Substantially Equivalent | Hospal Medical Corp. |
| K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER | May 08, 1979 | Substantially Equivalent | Medical, Inc. |
| K790533 | HD CAPILLARY FILM DIALYZER, MODEL 1001 | May 02, 1979 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K790001 | DIALYZER, MODEL F.M.D 150 | Mar 06, 1979 | Substantially Equivalent | Hospal Medical Corp. |
| K781966 | DIALYZER, MAGNIFLO 100 PARALLEL PLATE | Feb 21, 1979 | Substantially Equivalent | Erika, Inc. |
| K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE | Dec 15, 1978 | Substantially Equivalent | Medical, Inc. |
| K780700 | LUNDIA PLATE DISPOSABLE DIALYZER | Jul 17, 1978 | Substantially Equivalent | Gambro, Inc. |
| K780427 | RP-510/RP-514 PARALLEL PLATE DIALYZERS | May 19, 1978 | Substantially Equivalent | Hospal Medical Corp. |
| K772318 | DIALYZER STANDARD, CODE 5DM1780 | Jan 26, 1978 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K771354 | PARALLEL PLATE DIALYZERS | Sep 15, 1977 | Substantially Equivalent | Hospal Medical Corp. |
| K770858 | DIALYZER, ULTRADIFFUSER, DISPOSABLE | Jun 14, 1977 | Substantially Equivalent | Gambro, Inc. |
| K770578 | PARALLEL PLATE DIALYZER | Apr 15, 1977 | Substantially Equivalent | Cobe Laboratories, Inc. |