Cleared Traditional

K921257 - EURION LOTOS P HEARING AID

K921257 is an FDA 510(k) clearance for EURION LOTOS P HEARING AID, manufactured by Manro Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K921257 · Manro Corp. · Ear, Nose, Throat device
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May 1992
Decision
60d
Days
Class 1
Risk

K921257 is an FDA 510(k) clearance for the EURION LOTOS P HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Manro Corp. (Grand Rapids, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 60 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 Manro Corp. devices

FDA 510(k) Submission Details - K921257

510(k) Number K921257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date May 15, 1992
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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 K921257.
OTOSONIC ACS-IC
K922224 · Beltone Electronics Corp. · May 1992
TELEX MODEL M29 ITE CUSTOM HEARING AID
K922065 · Telex Communications, Inc. · May 1992
TELEX MODEL 28A ITE CUSTOM HEARING AID
K922066 · Telex Communications, Inc. · May 1992
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
K921656 · Siemens Hearing Instruments, Inc. · May 1992
RIONET HEARING AID HB-52S
K921829 · Authorized Hearing Systems, Inc. · Apr 1992
RIONET HEARING AID HB-52T
K921830 · Authorized Hearing Systems, Inc. · Apr 1992