Cleared Traditional

K943808 - RIONET HM-02

K943808 is an FDA 510(k) clearance for RIONET HM-02, manufactured by Rockwin Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K943808 · Rockwin Corp. · Ear, Nose, Throat device
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May 1995
Decision
293d
Days
Class 1
Risk

K943808 is an FDA 510(k) clearance for the RIONET HM-02. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Rockwin Corp. (Dekalb, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 293 days - an extended review 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: 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 Rockwin Corp. devices

FDA 510(k) Submission Details - K943808

510(k) Number K943808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1994
Decision Date May 24, 1995
Days to Decision 293 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 89d · This submission: 293d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K943808.
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K952263 · Siemens Hearing Instruments, Inc. · Jun 1995
RIONET HEARING AID HM-02
K951677 · Authorized Hearing Systems, Inc. · Jun 1995
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951896 · Siemens Hearing Instruments, Inc. · May 1995
THE MODEL ACAPPELLA IN THE EAR HEARING AID
K943961 · Telex Communications, Inc. · May 1995
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
K951067 · Resound Corp. · May 1995
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
K951068 · Resound Corp. · May 1995