Cleared Traditional

K894610 - CUSTOM TRAYS, KITS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K894610 · L H M Ent., Inc. · General & Plastic Surgery device
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Mar 1990
Decision
238d
Days
Class 1
Risk

K894610 is an FDA 510(k) clearance for the CUSTOM TRAYS, KITS. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by L H M Ent., Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 238 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all L H M Ent., Inc. devices

Submission Details

510(k) Number K894610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 20, 1989
Decision Date March 15, 1990
Days to Decision 238 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 114d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.