Identity
- Trade Name
- THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2 FDA PMA
- Generic Name
- Sharps needle destruction device FDA PMA
Identifiers
- PMA Number
- P960018 FDA PMA
- FDA Product Code
- MTV FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 880.6210 FDA PMA
- Regulation Number
- 880.6210 FDA PMA
- Advisory Committee
- General Hospital FDA PMA
- FDA Decision
- APRL FDA PMA
The Needlyzer Needle Destroyer Model ND2 is a Sharps Needle Destruction Device (generic name) designed to immediately oxidize and destroy used needles. It is intended for non-coated stainless steel needles ranging from 16 to 30 gauge and lengths of 4 to 52 mm, including hub butterfly-type needles and those attached to metal or plastic hubs or vacutainers.
This mobile device is intended for use in hospitals and other healthcare facilities as a single-use or reusable sharps disposal solution. It operates via oxidation to neutralize needles post-use, adhering to FDA_PMA authorization (PMA P960018) and classified under device class 2 (regulation number 880.6210). Sterility and MRI safety are not specified, and the device is supplied as a standalone unit for on-site use.
Frequently asked questions
What types of needles can the Needlyzer Model ND2 safely destroy, and why is this important for healthcare facilities?
The Needlyzer Model ND2 is designed to oxidize and destroy non-coated stainless steel needles ranging from 16 to 30 gauge and lengths of 4 to 52 mm, including hub butterfly-type needles and those attached to metal/plastic hubs or vacutainers. This specificity ensures compatibility with common hospital needles while preventing damage from coated or non-ferrous materials, which could impair the oxidation process. Facilities using a variety of needle types benefit from a single solution that handles standard sharps without requiring separate disposal methods.
Is the Needlyzer Model ND2 meant for single-use or reusable applications, and how does this affect its maintenance?
The Needlyzer Model ND2 is intended for use as either single-use or reusable, depending on facility preference and infection control protocols. As a reusable device, it requires periodic maintenance to ensure proper oxidation function, while single-use reduces upfront costs but may increase waste. The manufacturer’s instructions (not detailed here) would outline cleaning/sterilization steps for reusable units, though no sterility claims are made for either mode.
How does the Needlyzer Model ND2’s regulatory approval impact its use in hospitals, and what does the PMA status imply?
The Needlyzer Model ND2 holds an FDA Premarket Approval (PMA P960018), classifying it as a Class II device (regulation 880.6210) for mobile sharps destruction. This approval confirms the device’s safety and effectiveness for oxidizing needles in healthcare settings, though it does not imply MRI safety or sterility. Hospitals can rely on this status to ensure compliance with sharps disposal regulations while using it as a standalone solution for on-site needle neutralization.
What needle sizes and configurations should clinicians verify before using the Needlyzer Model ND2, and why?
Clinicians should confirm the needles are non-coated stainless steel, within the 16–30 gauge and 4–52 mm length range, and either standalone or attached to metal/plastic hubs or vacutainers. The device’s oxidation mechanism relies on these material properties—coatings (e.g., plastic, gold) or non-ferrous metals could disrupt the process, risking incomplete destruction. Butterfly-type hubs and vacutainer attachments are explicitly supported, but non-compliant needles may jam or fail to oxidize properly.
How is the Needlyzer Model ND2 supplied, and what considerations should facilities make for its on-site deployment?
The Needlyzer Model ND2 is supplied as a standalone mobile unit for direct on-site use in hospitals or healthcare facilities. Facilities should account for floor space, electrical access, and ventilation near the device’s location, as it operates via oxidation (likely thermal or chemical). While no MRI safety or sterility guarantees are provided, its portability allows placement near high-volume needle use areas (e.g., phlebotomy stations) to minimize transport risks of contaminated sharps.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P960018 | Class II | Active |
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Manufacturer
- Manufacturer
- Healthcare Products Plus, Inc.
Sources (1)
- FDA PMA P960018 24 fields · synced Sep 18, 2026