Cleared Traditional

VIBRO-COM COMMUNICATOR #8827 (K813057) - FDA 510(k) Clearance

K813057 · Sonic Systems, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
34d
Days
-
Risk

K813057 is an FDA 510(k) clearance for the VIBRO-COM COMMUNICATOR #8827. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Sonic Systems, Inc. (Walker, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Sonic Systems, Inc. devices

Submission Details

510(k) Number K813057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1981
Decision Date December 02, 1981
Days to Decision 34 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
55d faster than avg
Panel avg: 89d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -