510(k) · Cleared
Recalled · Class II · 2020Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PHU Intra-Abdominal Pressure Monitoring Device
Cleared on Aug 1, 2007 after a 191-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 1, 2007
- Review
- 191 days
- Class
- Class U
- Product code
- PHU
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK070201 Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001C.R. Bard, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK153655 Accuryn Monitoring SystemPotrero Medical, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK210570 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK240057 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK260756 TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
- Descendant · 2 generations on · 0 of its ownK221020 Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray…Potrero Medical, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K153655Accuryn Monitoring SystemPotrero Medical, Inc. · 2016 · cites it directly4descendants
- K210570TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021 · 2 generations on2descendants
- K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024 · 3 generations on1descendant
- K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026 · 4 generations on0descendants
- K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn…Potrero Medical, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070201 | Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001 | C.R. Bard, Inc. | 2007 | — |
| +1 | K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016 | — |
| +2 | K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2021 | — |
| +3 | K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024 | — |
| +4 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | 2026 | — |
| +2 | K221020 | Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F… | Potrero Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PHU device
- #1 K210570 TraumaGuard Intra-abdominal Pressure Sensing…score 5.9 · 3 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Twin Star Compartment Monitoring and Fluid Collection System Named without a submission number | |
| * | — | Bard Urodynamic Catheter Named without a submission number | |
| * | — | Wolfe Tory AbViser™ Intra-Abdominal Pressure Monitoring Kit Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153655 | Accuryn Monitoring System | 2016 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2020 | Class II | Z-1219-2020 | Device Design | 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 means, such as a new IAP system of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153655 (Potrero Medical, Inc., 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All PHU devicesPHU Intra-Abdominal Pressure Monitoring Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · PHU
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PHU
Too few PHU 510(k)s in any year since 2007 to give a median.
Recalls per year · PHU
No recall names PHU since 2007.
Adverse event reports per year · PHU
7in 2022
MAUDE reports naming product code PHU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 1 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070201: Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070201
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026