Cleared Traditional

K932734 - PHONAK PICO-FORTE SC-2

K932734 is the FDA 510(k) clearance for PHONAK PICO-FORTE SC-2 by Phonak, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K932734 · Phonak, Inc. · Ear, Nose, Throat device

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Jul 1993

Decision

50d

Days

Class 1

Risk

K932734 is an FDA 510(k) clearance for the PHONAK PICO-FORTE SC-2. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Phonak, Inc. (Naperville, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 50 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 Phonak, Inc. devices

Submission Details

510(k) Number	K932734 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 07, 1993
Decision Date	July 27, 1993
Days to Decision	50 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

39d faster than avg

Panel avg: 89d · This submission: 50d

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 739

Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K932734.

OTICON MF

K932670 · Oticon Corp. · Aug 1993

GOLD ASP MODULE, ITE

K933036 · Electone, Inc. · Aug 1993

SILVER COMPRESSION MODULE, ITE

K933042 · Electone, Inc. · Aug 1993

PHONAK PICO-FORTE SC-D-2

K932735 · Phonak, Inc. · Jul 1993

STARKEY TRILOGY II PROGRAMMABLE HEARING AID

K933113 · Starkey Laboratories, Inc. · Jul 1993

351-AGCO BEHIND-THE-EAR HEARING AID

K933095 · Telex Communications, Inc. · Jul 1993

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K932734

Phonak, Inc.

Naperville, IL · US

BILL LESIECKI

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Ear, Nose, Throat

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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