Cleared Traditional

K890194 - SHILEY SPECIALIZED TRACHEOSTOMY TUBE

K890194 is an FDA 510(k) clearance for SHILEY SPECIALIZED TRACHEOSTOMY TUBE, manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K890194 · Shiley, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
184d
Days
Class 2
Risk

K890194 is an FDA 510(k) clearance for the SHILEY SPECIALIZED TRACHEOSTOMY TUBE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 184 days - an extended review 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: 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.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K890194

510(k) Number K890194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1989
Decision Date July 20, 1989
Days to Decision 184 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
44d slower than avg
Panel avg: 140d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 60
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K890194.
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · Bivona Medical Technologies · Jan 1990
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613 · Bivona Medical Technologies · Oct 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · Bivona Medical Technologies · Oct 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129 · Bivona Medical Technologies · Feb 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130 · Bivona Medical Technologies · Feb 1989
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · Shiley, Inc. · Sep 1981