Cleared Traditional

K771188 - REVERSING CLICK GENERATOR RCG6 (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771188 · Teca, Inc. · Ear, Nose, Throat device
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Jul 1977
Decision
13d
Days
Class 2
Risk

K771188 is an FDA 510(k) clearance for the REVERSING CLICK GENERATOR RCG6. Classified as Generator, Electronic Noise (for Audiometric Testing) (product code ETS), Class II - Special Controls.

Submitted by Teca, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1120 - 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 Teca, Inc. devices

Submission Details

510(k) Number K771188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1977
Decision Date July 14, 1977
Days to Decision 13 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
76d faster than avg
Panel avg: 89d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETS Generator, Electronic Noise (for Audiometric Testing)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1120
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 Ear, Nose, Throat devices follow this clearance model.