Cleared Traditional

K893609 - TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)

K893609 is an FDA 510(k) clearance for TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR), manufactured by Leonides Y. Teves, M.D., P.A.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K893609 · Leonides Y. Teves, M.D., P.A. · Anesthesiology device
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Oct 1989
Decision
173d
Days
Class 2
Risk

K893609 is an FDA 510(k) clearance for the TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Leonides Y. Teves, M.D., P.A. (Bradenton, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 173 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 - K893609

510(k) Number K893609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1989
Decision Date October 30, 1989
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
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 218
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K893609.
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · Boston Medical Products, Inc. · Feb 1991
CUFFED LINDER NASOTRACHEAL AIRWAY
K900457 · Polamedco, Inc. · Apr 1990
APT TRACHEA TUBES
K896181 · Advanced Pulmonary Technologies, Inc. · Jan 1990
LASER SHIELDING TUBE
K894669 · Vitaid, Ltd. · Oct 1989
CONNELL-STEPHENS ENDO ANESS TUBE
K895132 · The Traumafuse Co. · Oct 1989
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989
K893609 · TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
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