Cleared Traditional

K951002 - AMENDMENTS TO MULTIFOCUS

K951002 is an FDA 510(k) clearance for AMENDMENTS TO MULTIFOCUS, manufactured by Oticon A/S. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K951002 · Oticon A/S · Ear, Nose, Throat device
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Sep 1995
Decision
203d
Days
Class 1
Risk

K951002 is an FDA 510(k) clearance for the AMENDMENTS TO MULTIFOCUS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon A/S (Thisted, DK). The FDA issued a Cleared decision on September 18, 1995 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Oticon A/S devices

FDA 510(k) Submission Details - K951002

510(k) Number K951002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date September 18, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 90d · This submission: 203d
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 K951002.
UNITRON MODEL SOUND F/X
K954430 · Unitron Industries, Inc. · Oct 1995
MAICO PRODIGY CIC SERIES
K954054 · Maico Hearing Instruments, Inc. · Sep 1995
3M MODEL 8295
K954067 · 3M Company · Sep 1995
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
K953770 · Rexton, Inc. · Sep 1995
PHONAK 9900 CIC
K953921 · Phonak, Inc. · Sep 1995
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT
K954038 · Argosy Electronics · Sep 1995