Cleared Traditional

BALANCE REHABILITATION UNIT (BRU) (K070085) - FDA 510(k) Clearance

K070085 · Medicaa (Uruguay) S.A. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
48d
Days
-
Risk

K070085 is an FDA 510(k) clearance for the BALANCE REHABILITATION UNIT (BRU). Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Medicaa (Uruguay) S.A. (Austin, US). The FDA issued a Cleared decision on February 26, 2007 after a review of 48 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 Medicaa (Uruguay) S.A. devices

Submission Details

510(k) Number K070085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2007
Decision Date February 26, 2007
Days to Decision 48 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
41d faster than avg
Panel avg: 89d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Peers - LXV Apparatus, Vestibular Analysis

All 21
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