Cleared Traditional

K926237 - O'BRIEN GONIOMETER

K926237 is an FDA 510(k) clearance for O'BRIEN GONIOMETER, manufactured by Sgarlato Laboratories, Inc.. The device is a Class 1 Neurology device with product code KQW cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K926237 · Sgarlato Laboratories, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K926237

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.

KQW Device Classification - Class 1, General Controls

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.

Regulatory Peers - KQW Goniometer, Nonpowered

All 10
Devices cleared under the same product code (KQW) and FDA review panel - the closest regulatory comparables to K926237.
DOBBHOFF(R) RETRIEVAL FORCEPS
K901744 · Biosearch Medical Products, Inc. · Jul 1990
HAND HELD GONIOMETER
K850082 · Chattanooga Group, Inc. · Apr 1985
FINGER BONIOMETER BK7506
K831550 · Fred Sammons, Inc. · Jun 1983
UNIVERSAL GONIMETER
K810441 · Fred Sammons, Inc. · Feb 1981
BK-7497 BULB DYNAMOMETER
K801715 · Fred Sammons, Inc. · Aug 1980
BK-7505 RADIOPAQUE GONIOMETER, 8
K801716 · Fred Sammons, Inc. · Aug 1980