Cleared Traditional

K902167 - CONTAIN(TM) LASER PLUME FILTER (FDA 510(k) Clearance)

Class I Orthopedic device.

K902167 · Arbor Technologies, Inc. · Orthopedic device
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Jan 1991
Decision
234d
Days
Class 1
Risk

K902167 is an FDA 510(k) clearance for the CONTAIN(TM) LASER PLUME FILTER. Classified as Evacuator, Vapor, Cement Monomer (product code JDY), Class I - General Controls.

Submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 234 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4220 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arbor Technologies, Inc. devices

Submission Details

510(k) Number K902167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1990
Decision Date January 04, 1991
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 122d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDY Evacuator, Vapor, Cement Monomer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4220
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.