# K082919: UC-Care Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Uc-Care Medical Systems, Ltd.
- Decided: Oct 27, 2008 after 27 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: 4 generations back to K851659 (1985). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042110: Beamcath, Beampoint AB (2005) Summary page 2.
- K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide, CIVCO Medical Instruments Co., Inc. (1997) Summary page 2.
- K963993: Rusch Simplastic Foley Catheterization Set, Rusch, Inc. (1996) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K082919
Methodology: https://510kreport.com/methodology