Cleared Traditional

K843729 - SHILEY DISPOS. CANNULA FENESTRATED LOW

K843729 is an FDA 510(k) clearance for SHILEY DISPOS. CANNULA FENESTRATED LOW, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K843729 · Shiley, Inc. · Anesthesiology device
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Oct 1984
Decision
25d
Days
Class 2
Risk

K843729 is an FDA 510(k) clearance for the SHILEY DISPOS. CANNULA FENESTRATED LOW. 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 October 19, 1984 after a review of 25 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

FDA 510(k) Submission Details - K843729

510(k) Number K843729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date October 19, 1984
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
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 44
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K843729.
LARYNGECTOMY TUBE, CUFFED
K860176 · Sheridan Catheter Corp. · Jan 1986
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · Bivona Medical Technologies · Jul 1985
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · Shiley, Inc. · Mar 1984