Cleared Traditional

SIEMENS MODEL 284 PP (K893576) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K893576 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
377d
Days
Class 1
Risk

K893576 is an FDA 510(k) clearance for the SIEMENS MODEL 284 PP. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on May 21, 1990 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Siemens Hearing Instruments, Inc. devices

Submission Details

510(k) Number K893576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date May 21, 1990
Days to Decision 377 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
288d slower than avg
Panel avg: 89d · This submission: 377d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 1366
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K893576.
Lyric4 Hearing Aid
K232999 · Sonova AG · Apr 2024
3M MODEL 8295
K954067 · 3M Company · Sep 1995
3M MODEL 8200P MULTIPRO BTE
K953543 · 3M Company · Aug 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854 · 3M Company · Jan 1995
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · 3M Company · Dec 1993
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · 3M Company · Oct 1991