510(k) · Cleared
Recalled · Class II · 2026Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on Dec 7, 2007 as substantially equivalent to K003289 (C.R. Bard, Inc., 2001) after a 281-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 7, 2007
- Review
- 281 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003289 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003289 Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated)…C.R. Bard, Inc. · 2001
- This deviceK070582 Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.…C.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 |
|---|---|---|---|---|---|
| −1 | K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex… | C.R. Bard, Inc. | 2001 | — |
| 0 (this device) | K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.… | 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 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 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 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 |
|---|---|---|---|
| * | K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil…Summary page 2…mperature-Sensing Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate (#K003289). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications… | 2001 |
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 |
|---|---|---|---|---|
| Jun 25, 2026 | Class II | Z-3115-2026 | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Jun 18, 2025 | Class II | Z-2462-2025 | Process design | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or… |
| Aug 5, 2021 | Class II | Z-2538-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2521-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K153655 (Potrero Medical, Inc., 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Bardex-8 Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore e -or Urotrack 224 monitor, or other 400-series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070582: Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070582
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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