Cleared Traditional

K926237 - O'BRIEN GONIOMETER (FDA 510(k) Clearance)

Class I Neurology device.

K926237 · Sgarlato Laboratories, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
234d
Days
Class 1
Risk

K926237 is an FDA 510(k) clearance for the O'BRIEN GONIOMETER. Classified as Goniometer, Nonpowered (product code KQW), Class I - General Controls.

Submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 234 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1520 - 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 Sgarlato Laboratories, Inc. devices

Submission Details

510(k) Number K926237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1992
Decision Date August 02, 1993
Days to Decision 234 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 148d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQW Goniometer, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1520
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.