Cleared Traditional

K151509 - GSI TympStar Pro Middle Ear Analyzer

K151509 is an FDA 510(k) clearance for GSI TympStar Pro Middle Ear Analyzer, manufactured by Diagnostic Group, Dba Grason-Stadler. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K151509 · Diagnostic Group, Dba Grason-Stadler · Ear, Nose, Throat device
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Jun 2015
Decision
21d
Days
Class 2
Risk

K151509 is an FDA 510(k) clearance for the GSI TympStar Pro Middle Ear Analyzer. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Diagnostic Group, Dba Grason-Stadler (Eden Prairie, US). The FDA issued a Cleared decision on June 25, 2015 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 874.1090 - 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 Diagnostic Group, Dba Grason-Stadler devices

FDA 510(k) Submission Details - K151509

510(k) Number K151509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date June 25, 2015
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 11
Devices cleared under the same product code (ETY) and FDA review panel - the closest regulatory comparables to K151509.
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