Cleared Traditional

BK-7513 STAINLESS STEEL GONIOMETER (K801718) - FDA 510(k) Clearance

Class I Neurology device.

K801718 · Fred Sammons, Inc. · Neurology device
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Aug 1980
Decision
11d
Days
Class 1
Risk

K801718 is an FDA 510(k) clearance for the BK-7513 STAINLESS STEEL GONIOMETER. Classified as Goniometer, Nonpowered (product code KQW), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 11 days - a notably fast clearance 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: 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K801718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 04, 1980
Days to Decision 11 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 148d · This submission: 11d
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.

Regulatory Peers - KQW Goniometer, Nonpowered

All 7
Devices cleared under the same product code (KQW) and FDA review panel - the closest regulatory comparables to K801718.
BK-7497 BULB DYNAMOMETER
K801715 · Fred Sammons, Inc. · Aug 1980
BK-7505 RADIOPAQUE GONIOMETER, 8
K801716 · Fred Sammons, Inc. · Aug 1980
BK-7511 BRASS GONIOMETER
K801717 · Fred Sammons, Inc. · Aug 1980
GONIOMETER, MED. INTER. STAND. BK-7512
K760301 · Fred Sammons, Inc. · Sep 1976
GONIOMETER, INTER. STAND. LARGE, BK7514
K760302 · Fred Sammons, Inc. · Sep 1976