SCL · Class II · 21 CFR 880.5570

FDA Product Code SCL: Allergen And Vaccine Delivery Needles

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.

Leading manufacturers include Anhui Tiankang Medical Technology Co., Ltd. and Asistan Medikal.

25
Total
25
Cleared
139d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 305d recently vs 133d historically

FDA 510(k) Cleared Allergen And Vaccine Delivery Needles Devices (Product Code SCL)

25 devices
1–24 of 25
Cleared Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
K250983
Asistan Medikal
General Hospital · 305d
Cleared Dec 06, 2022
Bifurcated Needle
K222385
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital · 120d

About Product Code SCL - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code SCL since 1976, with 25 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under SCL have taken an average of 305 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

SCL devices are reviewed by the General Hospital panel. Browse all General Hospital devices →