Intra-Abdominal Pressure Monitoring Device
The Intra-Abdominal Pressure Monitoring Device is used for monitoring abdominal intracompartmental pressure, typically using bladder pressure as a surrogate measure for intra-abdominal pressure in critically ill patients. It is classified as "Unclassified" (Class U) by the FDA, having received 510(k) clearance without formal class assignment, reviewed by the General and Plastic Surgery (SU) panel. The product code is PHU, and it is flagged as an implant given that it involves intrabody pressure measurement via an indwelling catheter. No regulation number or medical specialty is assigned.
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Basic Information
- Product Code
- PHU
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | Oct 29, 2021 | Substantially Equivalent | Sentinel Medical Technologies, LLC |
| K070201 | BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 | Aug 01, 2007 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.