FDA product code OSI: Bariatric Bed
OSI is the FDA product code for bariatric bed. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel. Devices under OSI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for OSI devices, 1 initiated in the last five years.
Definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Classification
| Field | Value |
|---|---|
| Device name | Bariatric Bed |
| Device class | Class II |
| Regulation | 21 CFR 880.5100 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for OSI devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-31.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code OSI?
OSI is the FDA product code for bariatric bed. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel.
What device class is OSI?
Class II, regulation 21 CFR 880.5100. Typical premarket route: 510(k) exempt.
Have OSI devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code OSI
- Run a recall and safety report across every OSI manufacturer
- Watch product code OSI 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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