Cleared Traditional

HYDRO-SPLINT A SPONGE-COMPRESS DRESS (K843400) - FDA 510(k) Clearance

Class I General Hospital device.

K843400 · Compression Splint Products, Inc. · General Hospital
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Oct 1984
Decision
55d
Days
Class 1
Risk

K843400 is an FDA 510(k) clearance for the HYDRO-SPLINT A SPONGE-COMPRESS DRESS. Classified as Splint, Extremity, Noninflatable, External, Sterile (product code FYH), Class I - General Controls.

Submitted by Compression Splint Products, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 55 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 Compression Splint Products, Inc. devices

Submission Details

510(k) Number K843400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1984
Decision Date October 24, 1984
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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.