Cleared Traditional

K772171 - EAR PIERCING DEVICE

K772171 is an FDA 510(k) clearance for EAR PIERCING DEVICE, manufactured by Robert C. Cameron. The device is a Class 1 Ear, Nose, Throat device with product code JYS cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K772171 · Robert C. Cameron · Ear, Nose, Throat device
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Jan 1978
Decision
46d
Days
Class 1
Risk

K772171 is an FDA 510(k) clearance for the EAR PIERCING DEVICE. Classified as Perforator, Ear-lobe (product code JYS), Class I - General Controls.

Submitted by Robert C. Cameron (Mchenry, US). The FDA issued a Cleared decision on January 3, 1978 after a review of 46 days - a notably fast clearance 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: 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 Robert C. Cameron devices

FDA 510(k) Submission Details - K772171

510(k) Number K772171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1977
Decision Date January 03, 1978
Days to Decision 46 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
43d faster than avg
Panel avg: 89d · This submission: 46d
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.