Cleared Traditional

VOX COMPANION (K860992) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K860992 · Bloomfield Research and Development, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
46d
Days
Class 1
Risk

K860992 is an FDA 510(k) clearance for the VOX COMPANION. Classified as Larynx, Artificial (battery-powered) (product code ESE), Class I - General Controls.

Submitted by Bloomfield Research and Development, Inc. (Hilton Head, US). The FDA issued a Cleared decision on May 2, 1986 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 874.3375 - 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 Bloomfield Research and Development, Inc. devices

Submission Details

510(k) Number K860992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1986
Decision Date May 02, 1986
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.

Device Classification

Product Code ESE Larynx, Artificial (battery-powered)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3375
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.