Cleared Traditional

K870767 - THE (CROM) TESTER (FDA 510(k) Clearance)

Class I Neurology device.

K870767 · Twin City Surgical, Inc. · Neurology device
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Mar 1987
Decision
19d
Days
Class 1
Risk

K870767 is an FDA 510(k) clearance for the THE (CROM) TESTER. Classified as Goniometer, Nonpowered (product code KQW), Class I - General Controls.

Submitted by Twin City Surgical, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 19 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 Twin City Surgical, Inc. devices

Submission Details

510(k) Number K870767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date March 17, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
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.