Cleared Traditional

K021540 - RUSCH EDGAR TUBE

K021540 is an FDA 510(k) clearance for RUSCH EDGAR TUBE, manufactured by Rusch Intl.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K021540 · Rusch Intl. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
83d
Days
Class 2
Risk

K021540 is an FDA 510(k) clearance for the RUSCH EDGAR TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021540

510(k) Number K021540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date August 01, 2002
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 240
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K021540.
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
RUSCH MICROLARYNGEAL TUBE
K023964 · Rusch Intl. · Dec 2002
MADETT
K021044 · Wolfe Tory Medical, Inc. · Sep 2002
SILICONE TRACHEAL T-TUBES
K013321 · Technical Products, Inc. · Jun 2002
POSITUBE
K000045 · Paraproducts, Inc. · Mar 2000
ILM ENDOTRACHEAL TUBE
K991580 · The Laryngeal Mask Co., Ltd. · Feb 2000
K021540 · RUSCH EDGAR TUBE
Download PDF FDA Summary Rusch Intl.