Cleared Traditional

K950851 - GENT-L-KARE TRACHEOSTOMY TRAYS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K950851 · Premium Plastics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
117d
Days
Class 1
Risk

K950851 is an FDA 510(k) clearance for the GENT-L-KARE TRACHEOSTOMY TRAYS. Classified as Tracheostomy And Nasal Suctioning Kit (product code LRQ), Class I - General Controls.

Submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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: 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.

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Submission Details

510(k) Number K950851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1995
Decision Date June 21, 1995
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 114d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRQ Tracheostomy And Nasal Suctioning Kit
Device Class Class 1 - General Controls
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.