FDA product code SBO: Bed-Patient Activity Monitoring System
SBO is the FDA product code for bed-patient activity monitoring system. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under SBO, 1 in the last five years. The average 510(k) review took 269 days (median 269); 269 days on average over the last three years.
Definition
A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters.
Classification
| Field | Value |
|---|---|
| Device name | Bed-Patient Activity Monitoring System |
| Device class | Class I |
| Regulation | 21 CFR 880.2400 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for SBO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 269 |
Top SBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Position Health, LLC | 1 | 2024-06-21 |
Most recent SBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233096 | Position Health, LLC | PRESSUREALERT® Pressure Monitoring System | 2024-06-21 | 269 |
Recalls for SBO devices
openFDA lists no recalls for product code SBO.
Frequently asked questions
What is FDA product code SBO?
SBO is the FDA product code for bed-patient activity monitoring system. It is a Class I device, regulated under 21 CFR 880.2400 and reviewed by the General Hospital panel.
What device class is SBO?
Class I, regulation 21 CFR 880.2400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code SBO?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most SBO clearances?
Position Health, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBO
- Run a recall and safety report across every SBO manufacturer
- Watch product code SBO 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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