Cleared Traditional

K962389 - EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE

K962389 is an FDA 510(k) clearance for EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE, manufactured by Unomedical Sdn Bhd. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K962389 · Unomedical Sdn Bhd · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
154d
Days
Class 2
Risk

K962389 is an FDA 510(k) clearance for the EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Unomedical Sdn Bhd (Tarpon Springs, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 154 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.

View all Unomedical Sdn Bhd devices

FDA 510(k) Submission Details - K962389

510(k) Number K962389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date November 21, 1996
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 164
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K962389.
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM
K973191 · Pulmonx · Feb 1998
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · Vital Signs, Inc. · Aug 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · Mallinckrodt Medical · Mar 1997
ESOPHAGEAL INTUBATION DETECTOR
K962098 · Kirk Specialty Systems · Oct 1996
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
K961837 · Rusch Intl. · Aug 1996
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
K955495 · Rusch, Inc. · Jun 1996