Bifurcated Needle
by Allergy Laboratories of Ohio, Inc.
510(k) K874249
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874249 | Date3 Nov 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Bifurcated Needle is a single-lumen hypodermic needle designed for in-vivo diagnostic skin testing. Its bifurcated tip facilitates precise puncture of the skin, enabling accurate allergen administration during allergy testing procedures. This device is classified under the classification name 'Needle, Hypodermic, Single Lumen' and is intended for use in general hospital settings. The bifurcated design distinguishes it from standard hypodermic needles, allowing for controlled and repeatable skin penetration.
The Bifurcated Needle is supplied as a single-use medical device, adhering to standard sterility and handling protocols for hypodermic needles. It is regulated under FDA 510(k) clearance (K874249) and falls under the product code FMI, with a classification as a Class II device. No additional regulatory status beyond the stated FDA_510K authorization is provided in the specifications. Storage and usage follow standard medical device guidelines for hypodermic needles, ensuring proper containment and disposal to prevent contamination or injury.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the bifurcated tip on this needle, and how does it differ from a standard hypodermic needle?
The bifurcated tip on the Bifurcated Needle is designed to facilitate precise and controlled puncture of the skin, allowing for accurate allergen administration during in-vivo diagnostic skin testing. Unlike standard hypodermic needles, which have a single, straight tip, this design enables repeatable and controlled skin penetration, which is particularly useful for ensuring consistent results in allergy testing procedures.
Is this needle intended for reuse, or is it meant to be used only once? How should it be handled to maintain sterility?
The Bifurcated Needle is explicitly supplied as a single-use medical device. Like all hypodermic needles, it must be handled with strict adherence to sterility protocols—opening only in a controlled environment, using it immediately after preparation, and disposing of it safely after one use to prevent contamination or injury. Reuse is not recommended or supported by the manufacturer.
What storage guidelines should be followed for this needle, and how should it be disposed of?
Storage follows standard medical device guidelines for hypodermic needles: keep the packaging intact and sealed until immediate use, store in a clean, dry environment away from direct sunlight or extreme temperatures, and avoid contamination. After use, dispose of the needle in a sharps container to prevent accidental needlestick injuries and ensure proper biohazard containment.
What regulatory pathway does this device follow, and what does the FDA classification mean for its use?
This device follows the FDA 510(k) clearance pathway, specifically under clearance number K874249, and is classified as a Class II device under product code FMI. The 'Substantially Equivalent' (SESE) decision indicates it meets FDA standards for safety and effectiveness comparable to legally marketed devices of its type. This classification ensures it adheres to rigorous manufacturing and performance standards for hypodermic needles used in diagnostic skin testing.