Cleared Traditional

K882360 - DERMAPIK

K882360 is an FDA 510(k) clearance for DERMAPIK, manufactured by Creative Scientific Equipment Corp.. The device is a Class 2 General Hospital device with product code SCL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K882360 · Creative Scientific Equipment Corp. · General Hospital
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Aug 1988
Decision
63d
Days
Class 2
Risk

K882360 is an FDA 510(k) clearance for the DERMAPIK. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Creative Scientific Equipment Corp. (Long Beach, US). The FDA issued a Cleared decision on August 9, 1988 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Creative Scientific Equipment Corp. devices

FDA 510(k) Submission Details - K882360

510(k) Number K882360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date August 09, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SCL Device Classification - Class 2, Special Controls

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.