Cleared Traditional

K853320 - FREQUENCY RESPONSE ANALYZER COMPUTER SY...

K853320 is an FDA 510(k) clearance for FREQUENCY RESPONSE ANALYZER COMPUTER SY..., manufactured by Rastronics USA, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K853320 · Rastronics USA, Inc. · Ear, Nose, Throat device
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Sep 1985
Decision
59d
Days
Class 2
Risk

K853320 is an FDA 510(k) clearance for the FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Rastronics USA, Inc. (Mountainside, US). The FDA issued a Cleared decision on September 27, 1985 after a review of 59 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 Rastronics USA, Inc. devices

FDA 510(k) Submission Details - K853320

510(k) Number K853320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date September 27, 1985
Days to Decision 59 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
30d faster than avg
Panel avg: 89d · This submission: 59d
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 K853320.
AUDIOMETER
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