Cleared Traditional

K903435 - SHILEY SPECIALIZED TRACHEOSTOMY TUBE

K903435 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 63-day FDA review.

K903435 · Shiley, Inc. · Anesthesiology device
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Oct 1990
Decision
63d
Days
Class 2
Risk

K903435 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 October 2, 1990 after a review of 63 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 - K903435

510(k) Number K903435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 02, 1990
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K903435.
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270 · Bivona Medical Technologies · Aug 1991
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967 · Bivona Medical Technologies · Jul 1991
TRACHEOSTOMY CARE KIT
K910362 · Megadyne Medical Products, Inc. · Apr 1991
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547 · Bivona Medical Technologies · Jan 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548 · Bivona Medical Technologies · Jan 1990
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613 · Bivona Medical Technologies · Oct 1989