# K042110: Beamcath

- Pathway: 510(k) (Traditional)
- Applicant: Beampoint AB
- Decided: Feb 25, 2005 after 204 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851659 (1985). 12 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003285: Exac Trac 2.0 (Novalis Body Module), Brainlab AG (2001) Summary page 1.
- K981424: Nomos Bat Ultrasound Localization and Positioning System, Nomos Corp. (1998) Summary page 1.
- K974419: Rusch Simplastic Councill Tip Catheter, Rusch, Inc. (1998) Summary page 1.
- K990500: Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C, The Kendal Co. (1999) Summary page 1.

## Most influential descendants
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own
- K140099: Lighthouse Urinary Catheter (2014), 0 descendants of its own
- K082919: UC-Care Positioning System (2008), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042110
Methodology: https://510kreport.com/methodology