FDA product code MSF: Hemodialyzer, Re-Use, High Flux
MSF is the FDA product code for hemodialyzer, re-use, high flux. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 8 510(k) submissions under MSF, from 5 different applicants. The average 510(k) review took 366 days (median 354).
Classification
| Field | Value |
|---|---|
| Device name | Hemodialyzer, Re-Use, High Flux |
| Device class | Class II |
| Regulation | 21 CFR 876.5860 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every MSF clearance
Top MSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 3 | 1998-03-11 |
| Althin Medical AB an Affiliate of Baxter Intl | 2 | 1998-07-23 |
| Gambro Renal Products | 1 | 2003-05-06 |
| Gambro Healthcare | 1 | 2000-10-26 |
| Renal Systems, Inc. | 1 | 1998-01-05 |
Most recent MSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023615 | Gambro Renal Products | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR | 2003-05-06 | 190 |
| K994390 | Gambro Healthcare | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | 2000-10-26 | 303 |
| K970679 | Althin Medical AB an Affiliate of Baxter Intl | ALTRA FLUX 200 HEMODIALYZER | 1998-07-23 | 514 |
| K970681 | Althin Medical AB an Affiliate of Baxter Intl | ALTRA NOVA 200 HEMODIALYZER | 1998-07-23 | 514 |
| K970653 | Baxter Healthcare Corp | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | 1998-03-11 | 383 |
Recalls for MSF devices
openFDA lists no recalls for product code MSF.
Frequently asked questions
What is FDA product code MSF?
MSF is the FDA product code for hemodialyzer, re-use, high flux. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel.
What device class is MSF?
Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSF?
Across 8 cleared submissions the average was 366 days from receipt to decision (median 354).
Which companies have the most MSF clearances?
Baxter Healthcare Corp (3); Althin Medical AB an Affiliate of Baxter Intl (2); Gambro Renal Products (1); Gambro Healthcare (1); Renal Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSF
- Run a recall and safety report across every MSF manufacturer
- Watch product code MSF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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