510(k) · Cleared
ClearedLighthouse Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seedings Life Science Ventures, LLC · EZL Catheter, Retention Type, Balloon
Cleared on Mar 4, 2014 as substantially equivalent to K131655 (Seedings Life Science Ventures, LLC, 2013) and 1 other predicate after a 47-day review. Its family tree reaches back 5 generations to 1985. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 4, 2014
- Review
- 47 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K851659 (1985). 15 ancestors in all. No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
- 4 generations backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
- 3 generations backK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
- 2 generations backK042110 BeamcathBeampoint AB · 2005
- 1 generation backK131655 Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC · 2013
- This deviceK140099 Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC · 2014
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 |
|---|---|---|---|---|---|
| −5 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −4 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| −3 | K981424 | Nomos Bat Ultrasound Localization and Positioning System | Nomos Corp. | 1998 | — |
| −2 | K042110 | Beamcath | Beampoint AB | 2005 | — |
| −1 | K131655 | Lighthouse (TM) Urinary Catheter | Seedings Life Science Ventures, LLC | 2013 | — |
| 0 (this device) | K140099 | Lighthouse Urinary Catheter | Seedings Life Science Ventures, LLC | 2014 | — |
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 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K131655 | Lighthouse (TM) Urinary CatheterSummary page 1…21 CFR 876.5130 Predicate Devices: (1) Lighthouse Urinary Catheter Manufacturer: Seedlings Life Science Ventures, LLC FDA 510(k) number: K131655 Classification Code: 78 EZL (2) BeamCath, Urological Catheter Patient Positioning Device Manufacturer:… | 2013 |
| * | K042110 | BeamcathSummary page 1…Classification Code: 78 EZL (2) BeamCath, Urological Catheter Patient Positioning Device Manufacturer: Beampoint AB FDA 510(k) number: K(042110 Classification Code: 78 EZL Seedlings Confidential Page 17 of 31 3rd 51l0k file_… | 2005 |
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 29 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Lighthouse TM Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140099: Lighthouse Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140099
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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