Cleared Traditional

K881417 - DAHLBERG MODEL GP BODY AID

K881417 is an FDA 510(k) clearance for DAHLBERG MODEL GP BODY AID, manufactured by Dahlberg Electronics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K881417 · Dahlberg Electronics, Inc. · Ear, Nose, Throat device
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Jun 1988
Decision
64d
Days
Class 1
Risk

K881417 is an FDA 510(k) clearance for the DAHLBERG MODEL GP BODY AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Dahlberg Electronics, Inc. (Golden Valley, US). The FDA issued a Cleared decision on June 7, 1988 after a review of 64 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 Dahlberg Electronics, Inc. devices

FDA 510(k) Submission Details - K881417

510(k) Number K881417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date June 07, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 89d · This submission: 64d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K881417.
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · Maico Hearing Instruments, Inc. · Aug 1988
HEARING AID, UNITRON MODEL UI5
K882375 · Unitron Industries, Inc. · Aug 1988
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692 · Maico Hearing Instruments, Inc. · Jul 1988
DAHLBERG MODEL XJ 8080 BODY-WORN HEARING AID
K881612 · Dahlberg Electronics, Inc. · Jun 1988
IMPULSE TVC (RICHARDS, OMNI, MARCON)
K881143 · Richards Medical Co., Inc. · May 1988
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
K880969 · Starkey Laboratories, Inc. · Apr 1988