Cleared Traditional

K092111 - ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

K092111 is an FDA 510(k) clearance for ENTOMED SCREENING AUDIOMETER, manufactured by Entomed AB. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K092111 · Entomed AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
80d
Days
Class 2
Risk

K092111 is an FDA 510(k) clearance for the ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMET.... Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Entomed AB (Malmo, SE). The FDA issued a Cleared decision on October 2, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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 Entomed AB devices

FDA 510(k) Submission Details - K092111

510(k) Number K092111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date October 02, 2009
Days to Decision 80 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
10d faster than avg
Panel avg: 90d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 134
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