Cleared Traditional

K872633 - MASTER-FIT HEARING EVALUA. & RECOM. (HE...

K872633 is an FDA 510(k) clearance for MASTER-FIT HEARING EVALUA. & RECOM. (HE..., manufactured by Hearing Health Care Program. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K872633 · Hearing Health Care Program · Ear, Nose, Throat device
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Sep 1987
Decision
72d
Days
Class 2
Risk

K872633 is an FDA 510(k) clearance for the MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Hearing Health Care Program (St. Paul., US). The FDA issued a Cleared decision on September 16, 1987 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Hearing Health Care Program devices

FDA 510(k) Submission Details - K872633

510(k) Number K872633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date September 16, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 89d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
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 - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 10
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K872633.
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K862162 · Phonic Ear, Inc. · Jul 1986
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K861857 · Phonic Ear, Inc. · Jun 1986