Cleared Traditional

THE BTE VECTOR (K925225) - FDA 510(k) Clearance

Also marketed or referenced as:
ANALYSIS SYSTEM FOR THE LOW BACK

Class I Neurology device.

K925225 · Baltimore Therapeutic Equipment Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
619d
Days
Class 1
Risk

K925225 is an FDA 510(k) clearance for the THE BTE VECTOR. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 619 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology 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: 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 Neurology submissions.

View all Baltimore Therapeutic Equipment Co. devices

Submission Details

510(k) Number K925225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date June 27, 1994
Days to Decision 619 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
471d slower than avg
Panel avg: 148d · This submission: 619d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.