Cleared Traditional

K860176 - LARYNGECTOMY TUBE, CUFFED

K860176 is an FDA 510(k) clearance for LARYNGECTOMY TUBE, manufactured by Sheridan Catheter Corp.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K860176 · Sheridan Catheter Corp. · Anesthesiology device
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Jan 1986
Decision
10d
Days
Class 2
Risk

K860176 is an FDA 510(k) clearance for the LARYNGECTOMY TUBE, CUFFED. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on January 27, 1986 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 - K860176

510(k) Number K860176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date January 27, 1986
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 58
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K860176.
MINI-TRACH KIT
K862167 · Portex, Inc. · Aug 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · Bivona Medical Technologies · Jun 1986
TRACHEOSTOMY CARE KIT
K855130 · Dynarex Corp. · Mar 1986
THE HOOD LIFE SAVER
K853511 · Hood Laboratories · Dec 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · Hood Laboratories · Dec 1985
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985