510(k) · Cleared
ClearedUC-Care Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uc-Care Medical Systems, Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Oct 27, 2008 as substantially equivalent to K042110 (Beampoint AB, 2005) and 2 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1985. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 27, 2008
- Review
- 27 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K851659 (1985). 18 ancestors in all. No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
- 3 generations backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
- 2 generations backK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
- 1 generation backK042110 BeamcathBeampoint AB · 2005
- This deviceK082919 UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008
Class I recalls in this family
- K990500 Kendall Ultramer Coude Foley Catheter, Model…2 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −3 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| −2 | K981424 | Nomos Bat Ultrasound Localization and Positioning System | Nomos Corp. | 1998 | — |
| −1 | K042110 | Beamcath | Beampoint AB | 2005 | — |
| 0 (this device) | K082919 | UC-Care Positioning System | Uc-Care Medical Systems, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 1 |
| 2001 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K042110 | BeamcathSummary page 2…DicevName' 77Date ]517k No of approval BeamCath K042110 25 Feb, 2005 Disposable Endocavity Ultrasound needle/Biopsy Guide Guide… | 2005 |
| * | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument GuideSummary page 2…K042110 25 Feb, 2005 Disposable Endocavity Ultrasound needle/Biopsy Guide Guide ~~~~~~~~~K970514 20 Jun, 1997 SimplasticTM Catheter K963993 17 Dec, 1996 Conclusion:… | 1997 |
| * | K963993 | Rusch Simplastic Foley Catheterization SetSummary page 2…y Guide Guide ~~~~~~~~~K970514 20 Jun, 1997 SimplasticTM Catheter K963993 17 Dec, 1996 Conclusion: UC-CARE Ltd. believes that, based on the information provid… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K042110.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 UC-CARE Positioning System is a mechanical positioning device, introduced into the urethra as a sterile urological catheter for visualizing the urethral course, aimed for assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures.
The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082919: UC-Care Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082919
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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