510(k) · Cleared
ClearedTraumaGuard Intra-abdominal Pressure Sensing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Medical Technologies, LLC · PHU Intra-Abdominal Pressure Monitoring Device
Cleared on Oct 29, 2021 as substantially equivalent to K153655 (Potrero Medical, Inc., 2016) after a 245-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 29, 2021
- Review
- 245 days
- Class
- Class U
- Product code
- PHU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003289 (2001). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003289 Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated)…C.R. Bard, Inc. · 2001
- 2 generations backK070582 Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.…C.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK153655 Accuryn Monitoring SystemPotrero Medical, Inc. · 2016
- This deviceK210570 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021
- Descendant · cites it directly · 1 of its ownK240057 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK260756 TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex… | C.R. Bard, Inc. | 2001 | — |
| −2 | K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.… | C.R. Bard, Inc. | 2007 | 4 |
| −1 | K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016 | — |
| 0 (this device) | K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2021 | — |
| +1 | K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024 | — |
| +2 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K153655 | Accuryn Monitoring SystemSummary page 4…Unclassified Predicate Device(s): The subject device is equivalent to the following device: x Accuryn Monitoring System (K153655) This predicate has not been subject to a design-related recall. Device Description: The Trauma… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K240057 (Sentinel Medical Technologies, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K153655.
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. 2021, 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?
TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210570: TraumaGuard Intra-abdominal Pressure Sensing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210570
Report an extraction error
Are you the manufacturer?
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