FDA product code MSE: Hemodialyzer, Re-Use, Low Flux
MSE is the FDA product code for hemodialyzer, re-use, low flux. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under MSE, from 4 different applicants. The average 510(k) review took 285 days (median 264). FDA has posted 2 recalls for MSE devices.
Classification
| Field | Value |
|---|---|
| Device name | Hemodialyzer, Re-Use, Low Flux |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| 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 MSE clearance
Top MSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 3 | 2000-11-15 |
| Asahi Medical Co., Ltd. | 2 | 1999-05-17 |
| Fresenius USA, Inc. | 1 | 1998-09-15 |
| Fresenius Medical Care North America | 1 | 1998-08-27 |
Most recent MSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001685 | Baxter Healthcare Corp | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | 2000-11-15 | 167 |
| K983720 | Asahi Medical Co., Ltd. | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- | 1999-05-17 | 208 |
| K970700 | Fresenius USA, Inc. | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | 1998-09-15 | 567 |
| K974090 | Fresenius Medical Care North America | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS | 1998-08-27 | 302 |
| K970654 | Baxter Healthcare Corp | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | 1997-11-12 | 264 |
Recalls for MSE devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-10-12.
Frequently asked questions
What is FDA product code MSE?
MSE is the FDA product code for hemodialyzer, re-use, low flux. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is MSE?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSE?
Across 7 cleared submissions the average was 285 days from receipt to decision (median 264).
Which companies have the most MSE clearances?
Baxter Healthcare Corp (3); Asahi Medical Co., Ltd. (2); Fresenius USA, Inc. (1); Fresenius Medical Care North America (1).
Have MSE devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2006-10-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MSE
- Run a recall and safety report across every MSE manufacturer
- Watch product code MSE 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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