Cleared Traditional

K925145 - TRACE MODEL #'S 840, 841, 842, 845

K925145 is an FDA 510(k) clearance for TRACE MODEL #'S 840, manufactured by Trace Medical Equipment, Inc.. The device is a Class 1 General Hospital device with product code FYH cleared through the Traditional 510(k) pathway after a 218-day FDA review.

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

FDA 510(k) Submission Details - K925145

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.

FYH Device Classification - Class 1, General Controls

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.

Regulatory Peers - FYH Splint, Extremity, Noninflatable, External, Sterile

Devices cleared under the same product code (FYH) and FDA review panel - the closest regulatory comparables to K925145.
SPECIALIST(R) WALKER
K924984 · Johnson & Johnson Orthopaedics, Inc. · Feb 1993
SPLINTS(ALL TYPE)
K852558 · The Huxley Instrument Corp. · Jul 1985
J & J DIP WATER ADDITIVE
K821693 · Johnson & Johnson Professionals, Inc. · Jul 1982
DELTA-LITE CASTING TAPE & SPLINTS
K802522 · Johnson & Johnson Professionals, Inc. · Jan 1981
ORTHOPEDIC LOWER EXTREMITY SUSPENSION
K801436 · Orthopedic Systems, Inc. · Jun 1980