Cleared Traditional

VMT SYSTEM (K971549) - FDA 510(k) Clearance

K971549 · Target Health, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
525d
Days
-
Risk

K971549 is an FDA 510(k) clearance for the VMT SYSTEM. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Target Health, Inc. (New York, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Target Health, Inc. devices

Submission Details

510(k) Number K971549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date October 05, 1998
Days to Decision 525 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
436d slower than avg
Panel avg: 89d · This submission: 525d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -