Lok-On Needle Disposal System
by Becton Dickinson Vacutainer Systems 510(k)
Active
510(k) K951886
Overview
The Lok-On Needle Disposal System is a Class II medical device designed for the safe disposal of used needles following venipuncture procedures. It is engineered to securely engage and contain needles, reducing the risk of accidental needle sticks and improving occupational safety in clinical settings. The system is intended for use with vacuum sample tubes, particularly those with anticoagulants, commonly used in clinical chemistry applications.
This device is supplied as a single-use, non-sterile accessory for needle disposal after phlebotomy. It is intended for use in healthcare environments where venipuncture is performed, such as laboratories, hospitals, and outpatient clinics. The system adheres to FDA 510(k) clearance under the product code GIM and is regulated under the Federal Food, Drug, and Cosmetic Act, specifically under regulation number 862.1675. No additional sterility or MRI safety considerations are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951886 | Date30 Jun 1995 | 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- Withdrawn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
- GIM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Becton Dickinson Vacutainer Systems
Questions
What is the primary purpose of the Lok-On Needle Disposal System in clinical settings?
The Lok-On Needle Disposal System is designed specifically to safely contain and dispose of used needles after venipuncture procedures. Its purpose is to reduce the risk of accidental needle sticks, which is a critical occupational safety concern for healthcare workers handling needles during blood draws, particularly when using vacuum sample tubes with anticoagulants for clinical chemistry testing.
Is the Lok-On Needle Disposal System intended for reuse, or is it meant to be used only once?
The Lok-On Needle Disposal System is explicitly supplied as a single-use accessory. This design ensures that each system is dedicated to one needle disposal event, minimizing the risk of contamination or cross-infection between patients or procedures.
What types of needles or tubes is this system compatible with, and where is it typically used?
The system is engineered for use with vacuum sample tubes containing anticoagulants, commonly used in clinical chemistry applications. It is intended for healthcare environments where venipuncture is performed, such as laboratories, hospitals, and outpatient clinics—anywhere blood samples are routinely collected for testing.
How is the Lok-On Needle Disposal System supplied, and does it require any special handling before use?
The system is supplied as a non-sterile accessory, meaning it does not require sterilization before use. However, standard infection control practices should still be followed when handling it, as it is designed for immediate use after needle disposal to ensure occupational safety. No additional preparation is needed beyond its intended single-use application.
What regulatory pathway was followed for FDA clearance of this device, and how does it relate to clinical chemistry?
The Lok-On Needle Disposal System received FDA 510(k) clearance under the product code GIM, with a decision classification of *Substantially Equivalent* (SESE). It was reviewed by the Clinical Chemistry (CH) Advisory Committee, reflecting its primary use in conjunction with vacuum tubes used for clinical chemistry testing. The clearance confirms its compliance with FDA regulations under the Federal Food, Drug, and Cosmetic Act (21 CFR 862.1675).