Cleared Traditional

K844051 - SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844051 · Washington-Greene County Branch Pennsylvania Assoc · Anesthesiology device
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Jan 1985
Decision
93d
Days
Class 2
Risk

K844051 is an FDA 510(k) clearance for the SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT. Classified as Tracheotomy Care Kit (product code NXA), Class II - Special Controls.

Submitted by Washington-Greene County Branch Pennsylvania Assoc (Washington, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Washington-Greene County Branch Pennsylvania Assoc devices

Submission Details

510(k) Number K844051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1984
Decision Date January 18, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 139d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXA Tracheotomy Care Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.