Cleared Traditional

K902167 - CONTAIN(TM) LASER PLUME FILTER

K902167 is an FDA 510(k) clearance for CONTAIN(TM) LASER PLUME FILTER, manufactured by Arbor Technologies, Inc.. The device is a Class 1 Orthopedic device with product code JDY cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K902167 · Arbor Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K902167

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.

JDY Device Classification - Class 1, General Controls

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.