Cleared Traditional

FAST TRACT TRANSTRACHEAL PROCEDURE KIT (K970018) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

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

Submission Details

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.

Device Classification

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 11
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K970018.
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DISPOSABLE NASAL SCISSOR
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DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994