Cleared Traditional

K812937 - BEHIND-THE-EAR MODEL 115

K812937 is an FDA 510(k) clearance for BEHIND-THE-EAR MODEL 115, manufactured by Danavox, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K812937 · Danavox, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
17d
Days
Class 1
Risk

K812937 is an FDA 510(k) clearance for the BEHIND-THE-EAR MODEL 115. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Danavox, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Danavox, Inc. devices

FDA 510(k) Submission Details - K812937

510(k) Number K812937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1981
Decision Date November 06, 1981
Days to Decision 17 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
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
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.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K812937.
RIONET HEARING AID HI-62
K813546 · Rion Acoustic Instruments, Inc. · Jan 1982
PHONIC EAR MODEL PE805CD
K813583 · Phonic Ear, Inc. · Jan 1982
HEARING AID MODEL UE9-R
K813229 · Unitron Industries, Inc. · Dec 1981
ELEGANCE
K812578 · Qualitone · Oct 1981
EAGLE I HEARING AID
K811988 · Electone, Inc. · Jul 1981
DAHLBERG MODEL AP HEARING AID
K811578 · Dahlberg Electronics, Inc. · Jul 1981