Cleared Traditional

K943460 - PORTAREM 2000

K943460 is an FDA 510(k) clearance for PORTAREM 2000, manufactured by Starkey Laboratories, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K943460 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
95d
Days
Class 2
Risk

K943460 is an FDA 510(k) clearance for the PORTAREM 2000. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Starkey Laboratories, Inc. devices

FDA 510(k) Submission Details - K943460

510(k) Number K943460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date October 21, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 90d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 19
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K943460.
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
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K952098 · Siemens Hearing Instruments, Inc. · May 1995
DESKREM-1000
K943459 · Starkey Laboratories, Inc. · Oct 1994
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371 · Madsen Electronics (Canada) , Ltd. · Feb 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372 · Madsen Electronics (Canada) , Ltd. · Feb 1989
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987