Cleared Traditional

K951768 - TEVES ECM PLUS THERMOCOUPLE

K951768 is an FDA 510(k) clearance for TEVES ECM PLUS THERMOCOUPLE, manufactured by Advanced Medical Concepts, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K951768 · Advanced Medical Concepts, Inc. · Anesthesiology device
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Dec 1995
Decision
242d
Days
Class 2
Risk

K951768 is an FDA 510(k) clearance for the TEVES ECM PLUS THERMOCOUPLE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Advanced Medical Concepts, Inc. (Brandenton, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 242 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 Advanced Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K951768

510(k) Number K951768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date December 15, 1995
Days to Decision 242 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 140d · This submission: 242d
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 189
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K951768.
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HEBELER SAFE-T-TUBE
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RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
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PRIMA GUEDEL AIRWAYS
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QUICK-LOCK
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