510(k) · Cleared
ClearedBeamcath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beampoint AB · EZL Catheter, Retention Type, Balloon
Cleared on Feb 25, 2005 as substantially equivalent to K003285 (Brainlab AG, 2001) and 3 other predicates after a 204-day review. Its family tree reaches back 3 generations to 1985. 1 of the 16 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 204 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K851659 (1985). 12 ancestors in all. 3 later devices descend from it, 3 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
- 2 generations backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
- 1 generation backK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
- This deviceK042110 BeamcathBeampoint AB · 2005
- Descendant · cites it directly · 1 of its ownK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013
- Descendant · cites it directly · 0 of its ownK140099 Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014
- Descendant · cites it directly · 0 of its ownK082919 UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008
Class I recalls in this family
- K990500 Kendall Ultramer Coude Foley Catheter, Model…direct predicate · 1999
Most influential descendants
Showing 3 of 3 · See all- K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013 · cites it directly1descendant
- K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014 · cites it directly0descendants
- K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −2 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| −1 | K981424 | Nomos Bat Ultrasound Localization and Positioning System | Nomos Corp. | 1998 | — |
| 0 (this device) | K042110 | Beamcath | Beampoint AB | 2005 | — |
| +1 | K131655 | Lighthouse (TM) Urinary Catheter | Seedings Life Science Ventures, LLC | 2013 | — |
| +1 | K140099 | Lighthouse Urinary Catheter | Seedings Life Science Ventures, LLC | 2014 | — |
| +1 | K082919 | UC-Care Positioning System | Uc-Care Medical Systems, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 1 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K003285 | Exac Trac 2.0 (Novalis Body Module)Summary page 1…earnpoint believes that, from a patient positioning indication for use, BeamiCath is substantially equivalent to predicate systems such as BrainLAB ExacTrac (K003285) and NOMOS BAT (K98 1424) devices. In additidn, Bearnpoint believes that, from a configuration and material composition sta… | 2001 |
| * | K981424 | Nomos Bat Ultrasound Localization and Positioning SystemSummary page 1…from a patient positioning indication for use, BeamiCath is substantially equivalent to predicate systems such as BrainLAB ExacTrac (K003285) and NOMOS BAT (K98 1424) devices. In additidn, Bearnpoint believes that, from a configuration and material composition standpoint, the BeamCa… | 1998 |
| * | K974419 | Rusch Simplastic Councill Tip CatheterSummary page 1…n and material composition standpoint, the BeamCath is substantially equivalent to the predicate urological catheters Rusch Simplastic Councill Tip Catheter (K974419) and the Kendall Ultramner Coude Foley Catheter (K990500). 3. Description of the Device The BeamCath is a positi… | 1998 |
| * | K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…Summary page 1…bstantially equivalent to the predicate urological catheters Rusch Simplastic Councill Tip Catheter (K974419) and the Kendall Ultramner Coude Foley Catheter (K990500). 3. Description of the Device The BeamCath is a positioning device used with external beam conformal radiation therap… | 1999 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 11 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 6.6 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131655 (Seedings Life Science Ventures, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K003285.
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 | — |
What is it indicated for?
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042110: Beamcath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042110
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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