FDA product code MDR: Binder, Medical, Therapeutic
MDR is the FDA product code for binder, medical, therapeutic. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel. Devices under MDR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 19 recalls for MDR devices.
Classification
| Field | Value |
|---|---|
| Device name | Binder, Medical, Therapeutic |
| Device class | Class I |
| Regulation | 21 CFR 880.5160 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for MDR devices
19 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-20.
Frequently asked questions
What is FDA product code MDR?
MDR is the FDA product code for binder, medical, therapeutic. It is a Class I device, regulated under 21 CFR 880.5160 and reviewed by the General Hospital panel.
What device class is MDR?
Class I, regulation 21 CFR 880.5160. Typical premarket route: 510(k) exempt.
Have MDR devices been recalled?
Yes: 19 product recalls across 1 recall events; the most recent began 2010-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MDR
- Run a recall and safety report across every MDR manufacturer
- Watch product code MDR 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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