Cleared Traditional

K921085 - PROGRAMMED AUDIOMETRIC DEVICE (PAD)/REC...

K921085 is an FDA 510(k) clearance for PROGRAMMED AUDIOMETRIC DEVICE (PAD)/REC..., manufactured by Hear-Well Technologies, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K921085 · Hear-Well Technologies, Inc. · Ear, Nose, Throat device
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May 1992
Decision
70d
Days
Class 2
Risk

K921085 is an FDA 510(k) clearance for the PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR). Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Hear-Well Technologies, Inc. (Guelph, CA). The FDA issued a Cleared decision on May 15, 1992 after a review of 70 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 Hear-Well Technologies, Inc. devices

FDA 510(k) Submission Details - K921085

510(k) Number K921085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1992
Decision Date May 15, 1992
Days to Decision 70 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
19d faster than avg
Panel avg: 89d · This submission: 70d
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 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K921085.
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MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991