Cleared Traditional

LX EMBEDDING CENTER (K853463) - FDA 510(k) Clearance

K853463 · Innovative Medical Systems, Inc. · Pathology device
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Aug 1985
Decision
9d
Days
-
Risk

K853463 is an FDA 510(k) clearance for the LX EMBEDDING CENTER.

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on August 28, 1985 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Pathology 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: 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 Innovative Medical Systems, Inc. devices

Submission Details

510(k) Number K853463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1985
Decision Date August 28, 1985
Days to Decision 9 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 77d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -