Cleared Traditional

K870470 - TRACH MATE TRACHEAL TUBE

K870470 is an FDA 510(k) clearance for TRACH MATE TRACHEAL TUBE, manufactured by Mccormick Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K870470 · Mccormick Laboratories, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
94d
Days
Class 2
Risk

K870470 is an FDA 510(k) clearance for the TRACH MATE TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mccormick Laboratories, Inc. (North Chelmsford, US). The FDA issued a Cleared decision on May 8, 1987 after a review of 94 days - within the typical 510(k) review window.

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 - K870470

510(k) Number K870470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date May 08, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
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 K870470.
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · Bivona Medical Technologies · Aug 1987
BELL/MCKAY TRACHEAL TUBE
K872616 · Sheridan Catheter Corp. · Aug 1987
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · American Pharmaseal Div. Ahsc · May 1987
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · Mallinckrodt Critical Care · Apr 1987
HOOD BIFURCATED T-TUBE
K864533 · Hood Laboratories · Mar 1987
WHITE-SIPOSS TUBE, CAT NO WS-1
K862950 · American Omni Medical, Inc. · Oct 1986
K870470 · TRACH MATE TRACHEAL TUBE
Download PDF Mccormick Laboratorie…