FDA product code MKW: Cyclosporine
MKW is the FDA product code for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. FDA has cleared 9 510(k) submissions under MKW, from 6 different applicants. The average 510(k) review took 103 days (median 36). 1 PMA application cites this product code. FDA has posted 5 recalls for MKW devices.
Classification
| Field | Value |
|---|---|
| Device name | Cyclosporine |
| Device class | Class II |
| Regulation | 21 CFR 862.1235 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MKW clearance
Top MKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 4 | 2006-08-21 |
| Siemens Medical Solutions Diagnostics | 1 | 2008-09-11 |
| Fujirebio Diagnostics,Inc. | 1 | 2008-09-11 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2008-08-05 |
| Abbott Laboratories, Inc. | 1 | 2004-04-30 |
1 more applicants have MKW clearances. See the full list in Caduvo.
Most recent MKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080751 | Fujirebio Diagnostics,Inc. | ARCHITECT CYCLOSPORINE | 2008-09-11 | 177 |
| K071455 | Siemens Medical Solutions Diagnostics | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | 2008-09-11 | 475 |
| K081992 | Siemens Healthcare Diagnostics, Inc. | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | 2008-08-05 | 22 |
| K062236 | Dade Behring, Inc. | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | 2006-08-21 | 19 |
| K053061 | Dade Behring, Inc. | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | 2006-02-06 | 98 |
Recalls for MKW devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MKW?
MKW is the FDA product code for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel.
What device class is MKW?
Class II, regulation 21 CFR 862.1235. Typical premarket route: 510(k).
How long does a 510(k) take for product code MKW?
Across 9 cleared submissions the average was 103 days from receipt to decision (median 36).
Which companies have the most MKW clearances?
Dade Behring, Inc. (4); Siemens Medical Solutions Diagnostics (1); Fujirebio Diagnostics,Inc. (1); Siemens Healthcare Diagnostics, Inc. (1); Abbott Laboratories, Inc. (1).
Have MKW devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2018-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MKW
- Run a recall and safety report across every MKW manufacturer
- Watch product code MKW 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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