System, Dialysate Delivery, Single Pass
The Single Pass Dialysate Delivery System is a hemodialysis device that delivers fresh dialysate in a continuous single-pass flow across the dialyzer membrane, removing it after one use. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIL, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
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Basic Information
- Product Code
- FIL
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K011741 | CRIT-LINE MONITOR III TQA (CLM TQA) | Jul 23, 2002 | Substantially Equivalent | Hemametrics |
| K901038 | SPS 550-IPS (INTEGRATED PATIENT STATION) | Apr 19, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | May 11, 1989 | Substantially Equivalent | Fresenius USA, Inc. |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Jun 27, 1979 | Substantially Equivalent | Cyberex Corp. |
| K781633 | ULTRAFILTRATION SCALE | Dec 07, 1978 | Substantially Equivalent | Extracorporeal Medical Specialities, Inc. |
| K771875 | ULTRAFILTRATION MONITOR 5M9034 | Nov 30, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K771227 | AK-10 | Aug 02, 1977 | Substantially Equivalent | Gambro, Inc. |
| K770137 | NEGATIVE PRESSURE ADAPTER 5M1350 | Feb 01, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
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.