Cleared Traditional

K864459 - RAIL CLAMP EXTENSION PIECE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K864459 · American Container Technology, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
19d
Days
Class 1
Risk

K864459 is an FDA 510(k) clearance for the RAIL CLAMP EXTENSION PIECE. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by American Container Technology, Inc. (Wallington, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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: 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 American Container Technology, Inc. devices

Submission Details

510(k) Number K864459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date December 01, 1986
Days to Decision 19 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
95d faster than avg
Panel avg: 114d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.