FDA product code INY: Bed, Patient Rotation, Manual
INY is the FDA product code for bed, patient rotation, manual. It is a Class I device, regulated under 21 CFR 890.5180 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under INY. The average 510(k) review took 115 days (median 115).
Classification
| Field | Value |
|---|---|
| Device name | Bed, Patient Rotation, Manual |
| Device class | Class I |
| Regulation | 21 CFR 890.5180 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INY clearance
Top INY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Concepts, Inc. | 1 | 1985-08-22 |
Most recent INY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851875 | Kinetic Concepts, Inc. | KINNET | 1985-08-22 | 115 |
Recalls for INY devices
openFDA lists no recalls for product code INY.
Frequently asked questions
What is FDA product code INY?
INY is the FDA product code for bed, patient rotation, manual. It is a Class I device, regulated under 21 CFR 890.5180 and reviewed by the Physical Medicine panel.
What device class is INY?
Class I, regulation 21 CFR 890.5180. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INY?
Across 1 cleared submissions the average was 115 days from receipt to decision (median 115).
Which companies have the most INY clearances?
Kinetic Concepts, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code INY
- Run a recall and safety report across every INY manufacturer
- Watch product code INY 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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