Cleared Traditional

K854341 - DELTA-LITE CASTING RESIN (FDA 510(k) Clearance)

Class I Orthopedic device.

K854341 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
25d
Days
Class 1
Risk

K854341 is an FDA 510(k) clearance for the DELTA-LITE CASTING RESIN. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on November 22, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K854341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date November 22, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
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.