Cleared Traditional

THE TELOS EQUIPMENT (K812778) - FDA 510(k) Clearance

Class I Radiology device.

K812778 · The Telos Co. · Radiology device
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Dec 1981
Decision
64d
Days
Class 1
Risk

K812778 is an FDA 510(k) clearance for the THE TELOS EQUIPMENT. Classified as Goniometer, Nonpowered (product code KQW), Class I - General Controls.

Submitted by The Telos Co. (Walker, US). The FDA issued a Cleared decision on December 8, 1981 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 888.1520 - the FDA radiology and imaging software oversight 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 The Telos Co. devices

Submission Details

510(k) Number K812778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date December 08, 1981
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
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 8
Devices cleared under the same product code (KQW) and FDA review panel - the closest regulatory comparables to K812778.
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
BK-7511 BRASS GONIOMETER
K801717 · Fred Sammons, Inc. · Aug 1980
BK-7513 STAINLESS STEEL GONIOMETER
K801718 · Fred Sammons, Inc. · Aug 1980