Cleared Traditional

K872616 - BELL/MCKAY TRACHEAL TUBE

K872616 is an FDA 510(k) clearance for BELL/MCKAY TRACHEAL TUBE, manufactured by Sheridan Catheter Corp.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K872616 · Sheridan Catheter Corp. · Anesthesiology device
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Aug 1987
Decision
35d
Days
Class 2
Risk

K872616 is an FDA 510(k) clearance for the BELL/MCKAY TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sheridan Catheter Corp. devices

FDA 510(k) Submission Details - K872616

510(k) Number K872616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date August 10, 1987
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 154
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K872616.
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
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