510(k) · Cleared
ClearedTraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Medical Technologies, · EZL Catheter, Retention Type, Balloon
Cleared on Sep 4, 2026 as substantially equivalent to K240057 (Sentinel Medical Technologies, LLC, 2024) after a 179-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 4, 2026
- Review
- 179 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003289 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK003289 Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated)…C.R. Bard, Inc. · 2001
- 4 generations backK070582 Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.…C.R. Bard, Inc. · 2007 · Recalled
- 3 generations backK153655 Accuryn Monitoring SystemPotrero Medical, Inc. · 2016
- 2 generations backK210570 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021
- 1 generation backK240057 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024
- This deviceK260756 TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex… | C.R. Bard, Inc. | 2001 | — |
| −4 | K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.… | C.R. Bard, Inc. | 2007 | 4 |
| −3 | K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 EZL? 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 EZL device
- #1 K262056 Rusch Latex Gold Foley Catheterscore 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemSummary page 5…evice(s): The subject device is equivalent to the following device: TraumaGuard Intra-abdominal Pressure Sensing System (K240057) This predicate has not been subject to a design-related recall. Device Description:… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The TraumaGuard Intra-abdominal Pressure-Sensing System is intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. 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/K260756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260756
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026