Cleared Traditional

SAUNDERS ELECTRONIC INCLINOMETER (K943898) - FDA 510(k) Clearance

Class I Neurology device.

K943898 · The Saunders Group · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
110d
Days
Class 1
Risk

K943898 is an FDA 510(k) clearance for the SAUNDERS ELECTRONIC INCLINOMETER. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by The Saunders Group (Chaska, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Saunders Group devices

Submission Details

510(k) Number K943898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1994
Decision Date November 28, 1994
Days to Decision 110 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
38d faster than avg
Panel avg: 148d · This submission: 110d
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.