Cleared Traditional

K961622 - PHONAK PICONET2 P2 AZ

K961622 is an FDA 510(k) clearance for PHONAK PICONET2 P2 AZ, manufactured by Phonak, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K961622 · Phonak, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
21d
Days
Class 1
Risk

K961622 is an FDA 510(k) clearance for the PHONAK PICONET2 P2 AZ. 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 May 17, 1996 after a review of 21 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

FDA 510(k) Submission Details - K961622

510(k) Number K961622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date May 17, 1996
Days to Decision 21 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
69d faster than avg
Panel avg: 90d · This submission: 21d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K961622.
RIONET HEARING AID HB53-K
K961907 · Authorized Hearing Systems, Inc. · Jul 1996
PHONAK SONA P2
K961653 · Phonak, Inc. · May 1996
ARGOSY PROGRAMMABLE
K961729 · Argosy Electronics · May 1996
CLARITY
K961670 · Seig Technologies, Inc. · May 1996
COMFORTONE PHS
K960741 · Comfortone America'S Value Hearing Aid Line · May 1996
DIGIFOCUS COMPACT
K961059 · Oticon, Inc. · May 1996