Cleared Traditional

K880285 - RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP

K880285 is an FDA 510(k) clearance for RICHARDS ITC TYPE HEARING AID MODEL IMP..., manufactured by Richards Medical Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K880285 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 1988
Decision
29d
Days
Class 1
Risk

K880285 is an FDA 510(k) clearance for the RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on February 23, 1988 after a review of 29 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K880285

510(k) Number K880285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date February 23, 1988
Days to Decision 29 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
61d faster than avg
Panel avg: 90d · This submission: 29d
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 954
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K880285.
MEMORYMATE HEARING AID MODEL 8200
K880082 · 3M Company · Mar 1988
ADDVANTAGE:TVC MARCON
K880284 · Richards Medical Co., Inc. · Feb 1988
RIONET HEARING AID HB-75
K874510 · Rion Acoustic Instruments, Inc. · Feb 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · Richards Medical Co., Inc. · Feb 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · Maico Hearing Instruments, Inc. · Feb 1988
SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
K880466 · Maico Hearing Instruments, Inc. · Feb 1988