Cleared Traditional

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

K250983 · Asistan Medikal · General Hospital

Jan 2026

Decision

305d

Days

Class 2

Risk

About This 510(k) Submission

K250983 is an FDA 510(k) clearance for the Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172), a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Asistan Medikal (Oguzeli, Gaziantep, TR). The FDA issued a Cleared decision on January 30, 2026, 305 days after receiving the submission on March 31, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K250983 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	January 30, 2026
Days to Decision	305 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.