Cleared Traditional

K133012 - SENTIERO

K133012 is an FDA 510(k) clearance for SENTIERO, manufactured by Path Medical GmbH. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K133012 · Path Medical GmbH · Ear, Nose, Throat device
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Jun 2014
Decision
257d
Days
Class 2
Risk

K133012 is an FDA 510(k) clearance for the SENTIERO. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Path Medical GmbH (Germering, Bavaria, DE). The FDA issued a Cleared decision on June 9, 2014 after a review of 257 days - an extended review 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: 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 Path Medical GmbH devices

FDA 510(k) Submission Details - K133012

510(k) Number K133012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date June 09, 2014
Days to Decision 257 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
167d slower than avg
Panel avg: 90d · This submission: 257d
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 143
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K133012.
ER36 Series OAE Test System
K150491 · Etymotic Research, Inc. · Mar 2015
NEURO-AUDIO
K141524 · Teleemg, LLC USA · Mar 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
K143395 · Otodynamics, Ltd. · Feb 2015
TITAN
K130795 · Interacoustics A/S · Jun 2013
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
K123624 · Mimosa Acoustics, Inc. · Mar 2013
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · Bio-Logic Systems Corp. · Nov 2012