Cleared Traditional

K930145 - PHONAK PICONET 231-X

K930145 is the FDA 510(k) clearance for PHONAK PICONET 231-X by Phonak, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K930145 · Phonak, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
20d
Days
Class 1
Risk

K930145 is an FDA 510(k) clearance for the PHONAK PICONET 231-X. 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 February 1, 1993 after a review of 20 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 K930145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date February 01, 1993
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
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 K930145.
VISTA 4000 SIGMA
K925600 · Unitron Industries, Inc. · Feb 1993
WIDEX MODEL D16
K926085 · Widex Hearing Aid Co., Inc. · Feb 1993
SOUNDCHOICE WITH VARIABLE SLOPE
K926476 · Bausch & Lomb, Inc. · Feb 1993
WIDEX MODEL D8 (HEARING AID)
K926244 · Widex Hearing Aid Co., Inc. · Jan 1993
P54-0 BEHIND THE EAR HEARING AID
K924887 · Electone, Inc. · Nov 1992
P54 HEARING AID
K924888 · Electone, Inc. · Nov 1992