Cleared Traditional

K893574 - SIEMENS MODEL 284 PP-AGC

K893574 is an FDA 510(k) clearance for SIEMENS MODEL 284 PP-AGC, manufactured by Siemens Hearing Instruments, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K893574 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
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May 1990
Decision
377d
Days
Class 1
Risk

K893574 is an FDA 510(k) clearance for the SIEMENS MODEL 284 PP-AGC. 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

FDA 510(k) Submission Details - K893574

510(k) Number K893574 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 90d · This submission: 377d
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 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K893574.
MODEL 366 HEARING AID
K900846 · Telex Communications, Inc. · May 1990
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K901642 · Widex Hearing Aid Co., Inc. · May 1990
SIEMENS MODEL 284 PP-L
K893573 · Siemens Hearing Instruments, Inc. · May 1990
SIEMENS MODEL 283 ASP
K893575 · Siemens Hearing Instruments, Inc. · May 1990
SIEMENS MODEL 284 PP
K893576 · Siemens Hearing Instruments, Inc. · May 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · Miracle-Ear, Inc. · Apr 1990