FDA product code PHU: Intra-Abdominal Pressure Monitoring Device
PHU is the FDA product code for intra-abdominal pressure monitoring device. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under PHU, from 2 different applicants. The average 510(k) review took 218 days (median 218). FDA has posted 1 recall for PHU devices.
Definition
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Classification
| Field | Value |
|---|---|
| Device name | Intra-Abdominal Pressure Monitoring Device |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PHU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 245 |
Compare with all 510(k) review times · Search every PHU clearance
Top PHU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sentinel Medical Technologies, LLC | 1 | 2021-10-29 |
| C.R. Bard, Inc. | 1 | 2007-08-01 |
Most recent PHU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210570 | Sentinel Medical Technologies, LLC | TraumaGuard Intra-abdominal Pressure Sensing System | 2021-10-29 | 245 |
| K070201 | C.R. Bard, Inc. | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 | 2007-08-01 | 191 |
Recalls for PHU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code PHU?
PHU is the FDA product code for intra-abdominal pressure monitoring device. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is PHU?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHU?
Across 2 cleared submissions the average was 218 days from receipt to decision (median 218).
Which companies have the most PHU clearances?
Sentinel Medical Technologies, LLC (1); C.R. Bard, Inc. (1).
Have PHU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-01-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PHU
- Run a recall and safety report across every PHU manufacturer
- Watch product code PHU 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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