Cleared Traditional

K021044 - MADETT

K021044 is an FDA 510(k) clearance for MADETT, manufactured by Wolfe Tory Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K021044 · Wolfe Tory Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
163d
Days
Class 2
Risk

K021044 is an FDA 510(k) clearance for the MADETT. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Wolfe Tory Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 163 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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.

FDA 510(k) Submission Details - K021044

510(k) Number K021044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date September 11, 2002
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 140d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 233
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K021044.
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
K032112 · Portex , Ltd. · Jan 2004
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
RUSCH MICROLARYNGEAL TUBE
K023964 · Rusch Intl. · Dec 2002
RUSCH EDGAR TUBE
K021540 · Rusch Intl. · Aug 2002
SILICONE TRACHEAL T-TUBES
K013321 · Technical Products, Inc. · Jun 2002
POSITUBE
K000045 · Paraproducts, Inc. · Mar 2000
K021044 · MADETT
Download PDF FDA Summary Wolfe Tory Medical, I…