# K070201: Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 1, 2007 after 191 days
- Product code: PHU (Intra-Abdominal Pressure Monitoring Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Twin Star Compartment Monitoring and Fluid Collection System: named in the summary without a submission number
- (no number) Bard Urodynamic Catheter: named in the summary without a submission number
- (no number) Wolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit: named in the summary without a submission number

## Most influential descendants
- K153655: Accuryn Monitoring System (2016), 4 descendants of its own
- K210570: TraumaGuard Intra-abdominal Pressure Sensing System (2021), 2 descendants of its own
- K240057: TraumaGuard Intra-abdominal Pressure Sensing System (2024), 1 descendant of its own
- K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) (2026), 0 descendants of its own
- K221020: Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (2023), 0 descendants of its own

## Recalls of this device
- Jan 13, 2020 · Class II · Z-1219-2020: Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other me

## Indications for use
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).

Source page: https://510kreport.com/device/K070201
Methodology: https://510kreport.com/methodology