Carefine Pen Needle Family Including Quintapoint and Superpoint
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141749 FDA 510(k)
- FDA Product Code
- FMI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Carefine Pen Needle Family is a hypodermic needle designed for subcutaneous insulin delivery, featuring a double-ended cannula mounted in an injection-molded hub with internal threads for attachment to pen injectors. It includes two distinct needle geometries: Quintapoint (5-bevel) and Superpoint, each optimized for ease of injection and septum penetration. The device is intended for single-use applications in both home and clinical settings, ensuring precision and reliability for insulin administration.
Supplied as single-use and sterile, the Carefine Pen Needle Family is intended for subcutaneous insulin delivery via pen injectors. The needles incorporate silicone-based lubrication and color-coded inner needle shields for length identification. Authorized under FDA 510(k) clearance (K141749) as substantially equivalent, the device adheres to regulatory standards for medical-grade hypodermic needles. Storage and handling follow standard sterile medical device protocols.
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. Sources consulted: Carefine Pen Needle Family Including Quintapoint and Superpoint ..., Carefine Pen Needle With Quintapoint and Superpoint (K140568) — Fda 510 ..., CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141749 | Class II | Active |
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Manufacturer
- Manufacturer
- Facet Technologies, LLC
Sources (1)
- FDA 510(k) K141749 24 fields · synced Oct 6, 2026