Cleared Traditional

K780694 - HEARING AID BATTERY CHARGER

K780694 is an FDA 510(k) clearance for HEARING AID BATTERY CHARGER, manufactured by Cahill Enterprises, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K780694 · Cahill Enterprises, Inc. · Ear, Nose, Throat device
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May 1978
Decision
18d
Days
Class 1
Risk

K780694 is an FDA 510(k) clearance for the HEARING AID BATTERY CHARGER. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Cahill Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 12, 1978 after a review of 18 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 Cahill Enterprises, Inc. devices

FDA 510(k) Submission Details - K780694

510(k) Number K780694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date May 12, 1978
Days to Decision 18 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
71d faster than avg
Panel avg: 89d · This submission: 18d
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 K780694.
HEARING AID, UNITRON MODEL 761P
K781502 · Unitron Industries, Inc. · Sep 1978
HEARING AID, UNITRON MODEL 975
K781434 · Unitron Industries, Inc. · Aug 1978
HEARING AID, UNITRON MODEL 958
K781439 · Unitron Industries, Inc. · Aug 1978
HEARING AID, EARETTE
K780654 · Oticon Corp. · Apr 1978
IN-THE-EAR HEARING AID, MODEL CE-3
K780309 · Starkey Laboratories, Inc. · Feb 1978
HEARING AID, BODY WORN
K780197 · Oticon Corp. · Feb 1978