Cleared Traditional

K970018 - FAST TRACT TRANSTRACHEAL PROCEDURE KIT

K970018 is an FDA 510(k) clearance for FAST TRACT TRANSTRACHEAL PROCEDURE KIT, manufactured by L.W. Ward and Assoc., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K970018 · L.W. Ward and Assoc., Inc. · Ear, Nose, Throat device
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Mar 1997
Decision
85d
Days
Class 1
Risk

K970018 is an FDA 510(k) clearance for the FAST TRACT TRANSTRACHEAL PROCEDURE KIT. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by L.W. Ward and Assoc., Inc. (Boulder, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 L.W. Ward and Assoc., Inc. devices

FDA 510(k) Submission Details - K970018

510(k) Number K970018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1997
Decision Date March 28, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 55
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