Solid State Continuous Flow Control Model W/K101
by Widran Urological Group, Ltd.
510(k) K861460
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861460 | Date2 May 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3780
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Solid State Continuous Flow Control Model W/K101 is a solid-state device designed for precise regulation of fluid flow in medical applications. It operates as a continuous flow control mechanism, ensuring consistent delivery of fluids without mechanical moving parts, which enhances reliability and reduces maintenance requirements.
This device is intended for use in controlled medical environments, supplied as a reusable instrument under regulatory oversight. It is classified under FDA 510(k) clearance (K861460) and falls under product code LJK, adhering to 21 CFR 866.3780. No specific sterility or MRI safety information is provided in the data, and its operational parameters are governed by the original authorization from 1986.
Other devices from Widran Urological Group, Ltd.
Questions
AI-generated answers, 19 Sep 2026
Is this device intended for single-use or can it be reused in clinical settings?
This device is explicitly described as a reusable instrument under regulatory oversight. Since it is classified under FDA 510(k) clearance (K861460) and lacks any mention of single-use requirements, it is designed for repeated use in controlled medical environments, provided proper cleaning and maintenance protocols are followed.
What types of medical applications is this device primarily used for, and why is it considered reliable?
The Solid State Continuous Flow Control Model W/K101 is designed for precise regulation of fluid flow in medical applications, particularly in controlled environments. Its reliability stems from its solid-state design, which eliminates mechanical moving parts, reducing wear and maintenance needs over time. This makes it suitable for applications requiring consistent, low-maintenance fluid delivery.
How is this device supplied, and what should clinicians consider when storing it?
The device is supplied as a reusable instrument, meaning it is not pre-sterilized or packaged for single-use. Since no specific sterility or storage instructions are provided in the data, clinicians should follow standard reusable medical device protocols, including cleaning, disinfection, and proper storage in a clean, dry environment to maintain functionality and prevent contamination. The lack of MRI safety information also suggests it should be stored away from electromagnetic interference.
What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?
This device was cleared through the FDA 510(k) process (K861460), specifically under a Traditional 510(k) review with a decision code of SESE (Substantially Equivalent). It falls under product code LJK and is governed by 21 CFR 866.3780, which relates to microbiology-related devices. This means it was deemed comparable to a legally marketed device at the time of clearance (1986) and is intended for use in controlled medical environments as originally authorized.