Needle-Ease Model 3500
by Millenium Medical Supply, Inc.
PMA P960044
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP960044 | Date6 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Needle-Ease Tm 2501
- 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
Overview
AI-generated summary, 18 Sep 2026
The Needle-Ease Model 3500 is a Sharps Needle Destruction Device, classified as a Class II medical device. It is designed to safely incinerate used diabetic needles, pen tips, and lancets—specifically 28–30 gauge needles, 29 and 30 gauge pen tips, and 23–26 gauge lancets—to mitigate the risk of needlesticks in home settings.
This device is intended for single-use by diabetic patients and operates by incinerating sharps through controlled combustion. Supplied as a standalone unit, it requires no additional sterilisation and is regulated under FDA PMA approval (P960044). Compliance with 21 CFR 880.6210 ensures adherence to safety standards for sharps destruction, with no MRI compatibility or reusable components specified.
Questions
AI-generated answers, 18 Sep 2026
What types of diabetic sharps can the Needle-Ease Model 3500 safely destroy, and why is this important for home use?
The Needle-Ease Model 3500 is designed to safely incinerate 28–30 gauge needles, 29 and 30 gauge diabetic pen tips, and 23–26 gauge lancets. This is important for home use because it reduces the risk of accidental needlesticks, which can occur when improperly disposing of sharps in household trash or recycling bins. The device’s controlled combustion process ensures these items are destroyed in a way that minimizes exposure hazards.
Is the Needle-Ease Model 3500 meant for repeated use, or is it intended to be used just once?
The Needle-Ease Model 3500 is explicitly designed for single-use by diabetic patients. Since it operates by incinerating sharps through combustion, it is not intended to be reused or cleaned for subsequent cycles. This design aligns with its purpose of providing a safe, one-time solution for sharps disposal in home settings.
How is the Needle-Ease Model 3500 supplied, and does it require any additional preparation before use?
The Needle-Ease Model 3500 is supplied as a standalone unit, meaning no additional components or accessories are needed for operation. It does not require sterilization before use, as it is intended for single-use disposal of used sharps. Simply load the device with the specified sharps, and it incinerates them through controlled combustion.
What regulatory pathway does the Needle-Ease Model 3500 follow, and what does this mean for its safety and compliance?
The Needle-Ease Model 3500 follows the FDA Premarket Approval (PMA) pathway, with approval granted under PMA number P960044. This means the device has undergone rigorous review to ensure its safety and effectiveness for its intended use—specifically, reducing the risk of needlesticks by incinerating diabetic sharps in home settings. Compliance with 21 CFR 880.6210 further ensures adherence to safety standards for sharps destruction.