Cleared Traditional

K911795 - KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) (FDA 510(k) Clearance)

K911795 · Breg, Inc. · Ear, Nose, Throat device
Nov 1991
Decision
211d
Days
-
Risk

K911795 is an FDA 510(k) clearance for the KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000). Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Breg, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K911795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date November 19, 1991
Days to Decision 211 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 158d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -