PHU
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intra-Abdominal Pressure Monitoring Device
- Device class
- Unclassified
- Medical specialty
- Unknown
- Flags
- Implant
- FDA definition
- Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
- Adverse events (MAUDE)
- 2017: 11 · 2018: 19 · 2019: 34 · 2020: 21 · 2021: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TraumaGuard Intra-abdominal Pressure Sensing System (K210570) | Sentinel Medical Technologies, LLC | 2021-10-29 |
| BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201) | C.R. Bard, Inc. | 2007-08-01 |
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Every clearance here is in the API, with alerts when new ones post.