Cleared Traditional

TRACE MODEL #'S 840, 841, 842, 845 (K925145) - FDA 510(k) Clearance

Class I General Hospital device.

K925145 · Trace Medical Equipment, Inc. · General Hospital
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May 1993
Decision
218d
Days
Class 1
Risk

K925145 is an FDA 510(k) clearance for the TRACE MODEL #'S 840, 841, 842, 845. Classified as Splint, Extremity, Noninflatable, External, Sterile (product code FYH), Class I - General Controls.

Submitted by Trace Medical Equipment, Inc. (Lisle, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.3910 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Trace Medical Equipment, Inc. devices

Submission Details

510(k) Number K925145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date May 19, 1993
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYH Splint, Extremity, Noninflatable, External, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3910
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.