Cleared Traditional

K922749 - LOW PROFILE TRACHEOSTOMY TUBE

K922749 is an FDA 510(k) clearance for LOW PROFILE TRACHEOSTOMY TUBE, manufactured by Concord/Portex. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K922749 · Concord/Portex · Anesthesiology device
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Sep 1992
Decision
86d
Days
Class 2
Risk

K922749 is an FDA 510(k) clearance for the LOW PROFILE TRACHEOSTOMY TUBE. 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 2, 1992 after a review of 86 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

FDA 510(k) Submission Details - K922749

510(k) Number K922749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date September 02, 1992
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
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 58
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K922749.
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996
MOORE TRACHEOSTOMY TUBE
K962240 · Boston Medical Products, Inc. · Aug 1996
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992
BIVONA TRACHEAL T-TUBE STENT
K920604 · Bivona Medical Technologies · Jul 1992