Cleared Traditional

KANIEVSKI SENSORY AID OR DEVICE (K843433) - FDA 510(k) Clearance

K843433 · Spectro Industries, Inc. · Ear, Nose, Throat device
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Nov 1984
Decision
71d
Days
-
Risk

K843433 is an FDA 510(k) clearance for the KANIEVSKI SENSORY AID OR DEVICE. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Spectro Industries, Inc. (Jenkintown, US). The FDA issued a Cleared decision on November 14, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Spectro Industries, Inc. devices

Submission Details

510(k) Number K843433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date November 14, 1984
Days to Decision 71 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
18d faster than avg
Panel avg: 89d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -