Cleared Traditional

K860678 - J.K. TEMPLETON EAR PIERCING GUNS/INSTRU...

K860678 is an FDA 510(k) clearance for J.K. TEMPLETON EAR PIERCING GUNS/INSTRU..., manufactured by Jay Kenny Templeton. The device is a Class 1 Ear, Nose, Throat device with product code JYS cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K860678 · Jay Kenny Templeton · Ear, Nose, Throat device
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Aug 1986
Decision
185d
Days
Class 1
Risk

K860678 is an FDA 510(k) clearance for the J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS. Classified as Perforator, Ear-lobe (product code JYS), Class I - General Controls.

Submitted by Jay Kenny Templeton (Sacremento, US). The FDA issued a Cleared decision on August 29, 1986 after a review of 185 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Jay Kenny Templeton devices

FDA 510(k) Submission Details - K860678

510(k) Number K860678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date August 29, 1986
Days to Decision 185 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 89d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

JYS Device Classification - Class 1, General Controls

Product Code JYS Perforator, Ear-lobe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.