Cleared Traditional

K874679 - TRACHEAL TUBE LASER SHIELD KIT

K874679 is an FDA 510(k) clearance for TRACHEAL TUBE LASER SHIELD KIT, manufactured by Americal Corp.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K874679 · Americal Corp. · Anesthesiology device
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Apr 1988
Decision
150d
Days
Class 2
Risk

K874679 is an FDA 510(k) clearance for the TRACHEAL TUBE LASER SHIELD KIT. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Americal Corp. (Mystic, US). The FDA issued a Cleared decision on April 11, 1988 after a review of 150 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 - K874679

510(k) Number K874679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date April 11, 1988
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 140d · This submission: 150d
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 219
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K874679.
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989
LINDER NASOTRACHEAL AIRWAY
K881496 · Polamedco, Inc. · May 1988
NDYAG LASER TRACHEAL TUBE
K880960 · Sheridan Catheter Corp. · Apr 1988
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · Mallinckrodt Critical Care · Nov 1987
NASOGASTRIC VOICETUBE
K871632 · American Omni Medical, Inc. · Sep 1987
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · Bivona Medical Technologies · Aug 1987
K874679 · TRACHEAL TUBE LASER SHIELD KIT
Download PDF Americal Corp.