Cleared Traditional

K852558 - SPLINTS(ALL TYPE) (FDA 510(k) Clearance)

Class I General Hospital device.

K852558 · The Huxley Instrument Corp. · General Hospital
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Jul 1985
Decision
15d
Days
Class 1
Risk

K852558 is an FDA 510(k) clearance for the SPLINTS(ALL TYPE). Classified as Splint, Extremity, Noninflatable, External, Sterile (product code FYH), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 15 days - a notably fast clearance 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: 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 Huxley Instrument Corp. devices

Submission Details

510(k) Number K852558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1985
Decision Date July 02, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
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.