Cleared Traditional

K893380 - QCR SYSTEM I AND QCR SYSTEM II (FDA 510(k) Clearance)

Class I Orthopedic device.

K893380 · Bremer Mfg. & Tool Co., Inc. · Orthopedic device
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Nov 1989
Decision
199d
Days
Class 1
Risk

K893380 is an FDA 510(k) clearance for the QCR SYSTEM I AND QCR SYSTEM II. Classified as Instrument, Cast Removal, Ac-powered (product code LGH), Class I - General Controls.

Submitted by Bremer Mfg. & Tool Co., Inc. (Winter Park, US). The FDA issued a Cleared decision on November 16, 1989 after a review of 199 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5960 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bremer Mfg. & Tool Co., Inc. devices

Submission Details

510(k) Number K893380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date November 16, 1989
Days to Decision 199 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 122d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGH Instrument, Cast Removal, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5960
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.