510(k) · Cleared
ClearedBardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil Temperature-Sensing Foley Catheter (LU
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 Jan 5, 2001 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 5, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK003289 Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated)…C.R. Bard, Inc. · 2001
- Descendant · cites it directly · 5 of its ownK070582 Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.…C.R. Bard, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK153655 Accuryn Monitoring SystemPotrero Medical, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK210570 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK240057 TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024
- Descendant · 5 generations on · 0 of its ownK260756 TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070582Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing…C.R. Bard, Inc. · 2007 · cites it directly5descendants
- K153655Accuryn Monitoring SystemPotrero Medical, Inc. · 2016 · 2 generations on4descendants
- K210570TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2021 · 3 generations on2descendants
- K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC · 2024 · 4 generations on1descendant
- K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003289 | Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex… | C.R. Bard, Inc. | 2001 | — |
| +1 | K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.… | C.R. Bard, Inc. | 2007 | 4 |
| +2 | K153655 | Accuryn Monitoring System | Potrero Medical, Inc. | 2016 | — |
| +3 | K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2021 | — |
| +4 | K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | 2024 | — |
| +5 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070582 | Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing… | 2007 | 5 |
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?
- Of its descendants, K070582 (C.R. Bard, Inc., 2007) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K003289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003289: Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil Temperature-Sensing Foley Catheter (LU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003289
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026