Cleared Traditional

SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE (K880614) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880614 · Shiley, Inc. · Anesthesiology device
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Mar 1988
Decision
22d
Days
Class 2
Risk

K880614 is an FDA 510(k) clearance for the SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 22 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 Shiley, Inc. devices

Submission Details

510(k) Number K880614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date March 09, 1988
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K880614.
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · Shiley, Inc. · Jan 1989
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · Shiley, Inc. · Feb 1988
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · Cook, Inc. · May 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987