NIR LAT Male External Catheter
by Mali, Inc. 510(k)
Active
510(k) K855209
Overview
This device is a Collector, Urine, (And Accessories) For Indwelling Catheter, designed for external urinary drainage in male patients. It functions as a non-invasive alternative to indwelling catheters, providing a sealed system to collect urine while maintaining patient comfort and hygiene. The catheter is intended for continuous or intermittent use to manage urinary incontinence or obstruction.
The NIR LAT Male External Catheter is supplied as a single-use, sterile device and is classified under FDA regulation 876.5250. It is intended for use in clinical settings such as hospitals, nursing homes, or home care environments. The device adheres to the skin via a breathable adhesive system and connects to a collection bag for urine disposal. Authorized under FDA 510K clearance (K855209), it is intended for male patients requiring external urinary drainage solutions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855209 | Date10 Jan 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KNX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5250
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mali, Inc.
Questions
What is the primary purpose of the NIR LAT Male External Catheter, and how does it differ from traditional indwelling catheters?
The NIR LAT Male External Catheter is designed as a non-invasive alternative to indwelling catheters for external urinary drainage in male patients. Unlike traditional indwelling catheters, which are inserted internally, this device adheres externally to the skin via a breathable adhesive system and collects urine in a sealed system connected to a collection bag. It is intended for continuous or intermittent use to manage urinary incontinence or obstruction while maintaining patient comfort and hygiene.
Is the NIR LAT Male External Catheter intended for single-use or reusable applications, and what does this mean for clinical workflow?
The NIR LAT Male External Catheter is explicitly supplied as a single-use, sterile device. This means each unit is intended for one patient application only, reducing the risk of cross-contamination and ensuring sterility. Clinically, this simplifies workflow by eliminating the need for reprocessing and ensures compliance with infection control protocols.
What types of clinical settings is this device authorized for, and how does its design support patient comfort?
The NIR LAT Male External Catheter is authorized for use in clinical settings such as hospitals, nursing homes, and home care environments. Its design incorporates a breathable adhesive system to secure the catheter to the skin, minimizing irritation and discomfort while allowing for airflow. This feature helps maintain patient comfort during continuous or intermittent use.
How is the NIR LAT Male External Catheter regulated, and what does this mean for purchasing or prescribing clinicians?
The NIR LAT Male External Catheter is regulated under FDA 510(k) clearance (K855209) and classified under FDA regulation 876.5250 as a Collector, Urine, (And Accessories) For Indwelling Catheter. This clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. For clinicians, this means the device has undergone regulatory review and is authorized for its intended use in male external urinary drainage.