FDA product code MDZ: Cleaners, Medical Devices
MDZ is the FDA product code for cleaners, medical devices. It is a Class II device, regulated under 21 CFR 880.6992 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under MDZ. The average 510(k) review took 795 days (median 795). FDA has posted 2 recalls for MDZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cleaners, Medical Devices |
| Device class | Class II |
| Regulation | 21 CFR 880.6992 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MDZ clearance
Top MDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Getinge International, Inc. | 2 | 1994-04-05 |
Most recent MDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920406 | Getinge International, Inc. | DECOMAT 228 | 1994-04-05 | 795 |
| K920413 | Getinge International, Inc. | DECOMAT A 8666 | 1994-04-05 | 795 |
Recalls for MDZ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-19.
Frequently asked questions
What is FDA product code MDZ?
MDZ is the FDA product code for cleaners, medical devices. It is a Class II device, regulated under 21 CFR 880.6992 and reviewed by the General Hospital panel.
What device class is MDZ?
Class II, regulation 21 CFR 880.6992. Typical premarket route: 510(k).
How long does a 510(k) take for product code MDZ?
Across 2 cleared submissions the average was 795 days from receipt to decision (median 795).
Which companies have the most MDZ clearances?
Getinge International, Inc. (2).
Have MDZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MDZ
- Run a recall and safety report across every MDZ manufacturer
- Watch product code MDZ 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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