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Lake Catheter Care Kit

by Lake Medical Products, Inc. 510(k)

Active United States

510(k) K872750

Overview

The Lake Catheter Care Kit is a urological catheter care system designed for the maintenance and cleaning of urinary catheters. It includes components and solutions to ensure proper hygiene and care of indwelling or external catheters, reducing the risk of infection and maintaining patient comfort.

This kit is intended for use in clinical settings such as hospitals, nursing homes, and home healthcare environments. Supplied as a single-use assembly, it adheres to FDA 510(k) clearance (K872750) under regulation 876.5130, classified as a Class II device. The kit is non-sterile and must be prepared and used according to medical guidelines to ensure proper catheter care.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872750 Date3 Sep 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of urinary catheters is the Lake Catheter Care Kit designed to maintain and clean, and where can it be used?

    The Lake Catheter Care Kit is specifically designed for the maintenance and cleaning of indwelling or external urinary catheters, helping to reduce infection risk and improve patient comfort. It is intended for use in clinical settings such as hospitals, nursing homes, and home healthcare environments, where proper catheter hygiene is critical.

  • Is the Lake Catheter Care Kit sterile, and how should it be prepared for use?

    The Lake Catheter Care Kit is non-sterile and must be prepared and used according to medical guidelines to ensure proper catheter care. Since it is a single-use assembly, it should be opened aseptically and used immediately after preparation, following standard infection control protocols.

  • How is the Lake Catheter Care Kit regulated, and what does its classification mean for clinical use?

    The Lake Catheter Care Kit holds FDA 510(k) clearance (K872750) under regulation 876.5130 and is classified as a Class II medical device. This classification indicates it has undergone rigorous review by the FDA’s Gastroenterology and Urology advisory committee to ensure safety and effectiveness for its intended use in catheter maintenance.

  • Can the Lake Catheter Care Kit be reused, or is it intended for single-use only?

    The Lake Catheter Care Kit is explicitly designed as a single-use assembly, meaning it should not be reused. Reuse could compromise hygiene and increase infection risks, so each kit should be discarded after one use in accordance with medical guidelines.