FDA product code OYS: Patient Bed With Canopy/Restraints
OYS is the FDA product code for patient bed with canopy/restraints. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under OYS. The average 510(k) review took 137 days (median 128). FDA has posted 1 recall for OYS devices, 1 initiated in the last five years.
Definition
Enclosed bed canopy system used as passive restraint.
Classification
| Field | Value |
|---|---|
| Device name | Patient Bed With Canopy/Restraints |
| Device class | Class I |
| Regulation | 21 CFR 880.6760 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OYS clearance
Top OYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. T. Posey Co. | 3 | 2012-05-02 |
Most recent OYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113355 | J. T. Posey Co. | POSEY BED | 2012-05-02 | 170 |
| K113357 | J. T. Posey Co. | POSEY BED | 2012-03-21 | 128 |
| K103817 | J. T. Posey Co. | POSEY BED | 2011-04-22 | 114 |
Recalls for OYS devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-14.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OYS?
OYS is the FDA product code for patient bed with canopy/restraints. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel.
What device class is OYS?
Class I, regulation 21 CFR 880.6760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OYS?
Across 3 cleared submissions the average was 137 days from receipt to decision (median 128).
Which companies have the most OYS clearances?
J. T. Posey Co. (3).
Have OYS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OYS
- Run a recall and safety report across every OYS manufacturer
- Watch product code OYS 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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