Cleared Traditional

Bifurcated Needle

K222385 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital

Dec 2022

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K222385 is an FDA 510(k) clearance for the Bifurcated Needle, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on December 6, 2022, 120 days after receiving the submission on August 8, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K222385 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2022
Decision Date	December 06, 2022
Days to Decision	120 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	SCL — Allergen And Vaccine Delivery Needles
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.