Cleared Traditional

K162917 - Allerhope Allergy Skin Tester (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162917 · Procare Industrial Co., Limited · General Hospital
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Aug 2017
Decision
303d
Days
Class 2
Risk

K162917 is an FDA 510(k) clearance for the Allerhope Allergy Skin Tester. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Procare Industrial Co., Limited (Zhengzhou, CN). The FDA issued a Cleared decision on August 17, 2017 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Procare Industrial Co., Limited devices

Submission Details

510(k) Number K162917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2016
Decision Date August 17, 2017
Days to Decision 303 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 128d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCL Allergen And Vaccine Delivery Needles
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.