Q 103 Needle Management System
by Qcare International, LLC PMA
Active
PMA P980020
Overview
The Q 103 Needle Management System is a Sharps Needle Destruction Device, classified as a Class II medical device. It is designed to safely sever and store used hypodermic needles from insulin syringes (1/2 inch length, gauges 28–29) to prevent accidental needle sticks and ensure proper disposal.
Intended for use in a home care environment, this system is a single-use device that requires no sterilisation. It operates under FDA_PMA approval (P980020) and is regulated under 21 CFR 880.6210, ensuring compliance with sharps management standards. The device is supplied as a standalone unit, with no additional components or accessories required beyond the needle itself.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP980020 | Date21 Dec 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Sharps needle destruction device
- PMA Number
- FDA Product Code
- MTV
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6210
- Advisory Committee
- General Hospital
- FDA Decision
- APRL
Questions
What types of needles is the Q 103 Needle Management System designed to handle, and why is this important for home use?
The Q 103 is specifically designed to safely sever and store used hypodermic needles from insulin syringes that are 1/2 inch in length and gauges 28–29. This is important for home use because it ensures accidental needle sticks are prevented during disposal, reducing the risk of infection or injury in a home care setting where sharps management must be both convenient and secure.
Is the Q 103 Needle Management System reusable, or is it meant for single-use only? How does this affect its use in a home setting?
The Q 103 is a single-use device, meaning it is intended for one-time use only after severing and storing a needle. This design choice simplifies disposal for home users, as there’s no need for cleaning, sterilization, or reprocessing—just replace it after each use to maintain safety and hygiene.
How is the Q 103 Needle Management System supplied, and do I need any additional components to use it?
The Q 103 is supplied as a standalone unit—no extra accessories or components are required beyond the needle itself. This makes it easy to use at home without needing to source additional materials, ensuring simplicity for patients managing insulin therapy.
Does the Q 103 Needle Management System require sterilization before or after use, and why?
No sterilization is required before or after use. The device is designed as a single-use, non-sterile system, which aligns with its intended purpose for home care. This eliminates the need for additional preparation or cleaning steps, making it user-friendly for patients.
What regulatory approval does the Q 103 Needle Management System have, and how does this affect its use in clinical settings?
The Q 103 is approved under an FDA Premarket Approval (PMA) with the designation P980020, regulated under 21 CFR 880.6210. This approval confirms its compliance with safety and performance standards for sharps management in home care environments, ensuring it meets regulatory requirements for use in clinical and patient settings.