Cleared Traditional

K771357 - GROUP AUDITORY TRAINER HC 431R

K771357 is an FDA 510(k) clearance for GROUP AUDITORY TRAINER HC 431R, manufactured by Hc Electronics. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K771357 · Hc Electronics · Ear, Nose, Throat device
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Jul 1977
Decision
7d
Days
Class 2
Risk

K771357 is an FDA 510(k) clearance for the GROUP AUDITORY TRAINER HC 431R. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Hc Electronics (Mchenry, US). The FDA issued a Cleared decision on July 29, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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.

FDA 510(k) Submission Details - K771357

510(k) Number K771357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1977
Decision Date July 29, 1977
Days to Decision 7 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
83d faster than avg
Panel avg: 90d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EPF Device Classification - Class 2, Special Controls

Product Code EPF Hearing Aid, Group And Auditory Trainer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
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.