Product Code: FII
FDA class 2
21 CFR 876.5860
System, Dialysate Delivery, Sealed
Gastroenterology, Urology
The Sealed Dialysate Delivery System is a closed-system device that prepares and delivers dialysate solution to the dialyzer during hemodialysis, using a sealed architecture to minimize contamination risk. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FII, regulated under 21 CFR 876.5860, within the Gastroenterology, Urology specialty.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
21
Basic Information
- Product Code
- FII
- Device Class
- FDA class 2
- Regulation Number
- 876.5860
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K030470 | NXSTAGE SYSTEM ONE | Jul 07, 2003 | Substantially Equivalent | NXSTAGE MEDICAL, INC. |
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | Aug 24, 1988 | Substantially Equivalent | GAMBRO, INC. |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Oct 13, 1987 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
| K862716 | HEMOFILTRATION SYSTEM 10 | Sep 09, 1986 | Substantially Equivalent | GAMBRO, INC. |
| K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | Oct 06, 1982 | Substantially Equivalent | HOSPAL MEDICAL CORP. |