Cleared Traditional

K844637 - WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K844637 · Dow Corning Corp. Healthcare Industries Materials · Chemistry device
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Jun 1985
Decision
203d
Days
Class 3
Risk

K844637 is an FDA 510(k) clearance for the WHITESIDE ACRYLIC CEMENT SPACER SLEEVE. Classified as Hyaline Membrane Disease Assay (product code LTC), Class III - Premarket Approval.

Submitted by Dow Corning Corp. Healthcare Industries Materials (P.O. Box 1767 Midland, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 203 days - an extended review cycle.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dow Corning Corp. Healthcare Industries Materials devices

Submission Details

510(k) Number K844637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1984
Decision Date June 19, 1985
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LTC Hyaline Membrane Disease Assay
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.