Cleared Traditional

K903730 - D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOM...

K903730 is the FDA 510(k) clearance for D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOM... by Concord/Portex. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K903730 · Concord/Portex · Anesthesiology device
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Sep 1990
Decision
40d
Days
Class 2
Risk

K903730 is an FDA 510(k) clearance for the D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 40 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 Concord/Portex devices

Submission Details

510(k) Number K903730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date September 25, 1990
Days to Decision 40 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 140d · This submission: 40d
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 23
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K903730.
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
K192511 · Venner Medical (Singapore) Pte, Ltd. · Jul 2020
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
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
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614 · Shiley, Inc. · Mar 1988